

#### [8] prime-vitality-inc-dba-prime-peptides-695156-12102024 | issued 12/10/2024 | Prime Vitality, Inc. dba Prime Peptides | SUBJ: Unapproved New Drugs/Misbranded
WARNING LETTER 695156 December 10, 2024 Dear Curtis Miller: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://primepeptides.co in October 2024 and has observed that your website offers various products as “peptides” including, “Semaglutide” and “Retatrutide.” We have also reviewed your social media websites at www.facebook.com/primepeptidesco, www.instagram.com/primepeptidesco, and www.youtube.com/@PrimePeptide. Your social media websites direct consumers to your https://primepeptides.co website to purchase your products. As described below, your “Semaglutide” and “Retatrutide” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Despite statements on your product labeling marketing your products for “research purposes only” and “not for human consumption or clinical use,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. [B163] Examples of claims observed on your websites that establish the intended use of your products as drugs for human use include, but may not be limited to, the following: On your webpage https://primepeptides.co/products/buy-semaglutide: • “Semaglutide reduces cardiovascular events. The SELECT trial showed that semaglutide reduced major adverse cardiovascular events by 20% in adults with preexisting cardiovascular disease and obesity. This included fewer heart attacks and strokes compared to those on placebo.” • “Semaglutide improves insulin resistance. A study found that semaglutide helped improve insulin sensitivity in participants, which is crucial for managing and preventing type 2 diabetes. This improvement was seen alongside significant weight loss.” • “Mechanism of Action[,] GLP-1 Receptor Activation[,] Appetite Regulation[,] Slowing Gastric Emptying[,] Enhancing Insulin Secretion[,] Reducing Glucagon Production[,] Cardiovascular Benefits[,and] Energy Expenditure and Lipid Metabolism” On your webpage https://primepeptides.co/products/buy-retatrutide: • “Retatrutide improves glycemic control. In a study involving patients with type 2 diabetes, retatrutide reduced HbAlc levels by up to 2.02% at 24 weeks. This indicates better blood sugar control, which is crucial for managing diabetes.” • “Retatrutide enhances cardiometabolic health. Participants in the trial experienced improvements in cardiometabolic measures, including reductions in waist circumference, blood pressure, and lipid levels. For examples, waist circumference decreased by up to 19.6 cm in some participants.” • “Retatrutide reduces liver fat. A 48-week study showed that retatrutide significantly reduced liver fat in obese patients. Those taking 8 mg and 12 mg doses saw liver fat reductions of 23.8% and 25.9% respectively, which is beneficial for liver health.” On your blog post “Top Weight Loss Peptides: Semaglutide, Tirzepatide & More” on your webpage https://primepeptides.co/blogs/peptides/weight-loss-peptides: • “Top Peptides for Weight Loss: A Quick Guide” with a graphic of a woman with a measuring tape around her waist. o “Semaglutide . . .Pros: Reduces body weight, controls blood sugar levels, FDA-approved for weight management . . . Statistics: Clinical trials show up to 15% body weight loss” o “Retatrutide . . . Pros: Targets 3 pathways, most weight loss, treats fatty live . . . Fun Fact: Known as the ‘triple agonist’ for its multi-pathway approach. Statistics: Early trials indicate up to 25% body weight loss.” • “Semaglutide can help people who are obese or overweight lose a considerable amount of weight and lower their risk of heart disease, diabetes, and cancer when used in combination with diet and exercise.” • “Retatrutide is an emerging peptide developed by Lilly for treating obesity, diabetes, and fatty liver disease. It is common for diabetes medications to be used for weight management, and Retatrutide is a notable example of this trend.” On your social media websites at www.facebook.com/primepeptidesco and www.instagram.com/primepeptidesco: • June 28, 2024 post: “Thanks so much for sharing your experience. We’re so happy to hear you’re loving the benefits! Semaglutide is a GLP-1 receptor agonist known for its significant impact on weight loss, glycemic control, and cardiovascular risk reduction. . . Safe & Effective: Trusted by health professionals worldwide . . . #shareyourexperience #sharingexperience . . . #fitness” with an image of a vial of semaglutide and the text “‘Highly Recommend[,]’ I’ve been using Semaglutide for a few months, and it’s been a game changer. My health and energy levels have improved significantly!” • June 23, 2024 post: “Customer Review Highlight! . . . Hearing about your positive experience means everything to us. So glad you’re loving the benefits! . . . Retatrutide is a new medicine that helps control blood sugar and supports weight loss. . . . Safe & Effective: Trusted by health professionals worldwide . . . #shareyourexperience #sharingexperience . . . #fitness” with an image of a woman in active sportswear, a vial of retatrutide and the text “TESTIMONIALS . . . ‘Impressive Weight Loss[,]’ Retatrutide has been impressive for my weight loss journey. I’ve seen significant results in just a few weeks. Highly recommend!” On your YouTube website at www.youtube.com/@PrimePeptide, August 30, 2024 post “Top 5 Peptides for Weight Loss”: • From the text below the video: “Top 5 Peptides for Weight Loss │Effective Fat-Burning Peptides . . . Learn how these peptides work, their potential benefits, and how they can help you achieve your weight loss goals. What You’ll Learn: How Semaglutide and Tirzepatide mimic natural hormones to reduce appetite and promote fat loss. The triple-action approach of Retatrutide for maximum weight reduction.” • From the video: “GLP-1 peptides also improve your overall health by controlling blood sugar and lowering the risk for heart problems, which are often an issue for people who are overweight. Let’s start by talking about the most popular weight loss peptide, semaglutide. Semaglutide is a medication that can help people with weight-related health issues like type 2 diabetes, high cholesterol, and high blood pressure.” • From the video: “Another exciting peptide is retatrutide. It was developed by Lilly for treating obesity, diabetes, and fatty liver disease . . . What sets retatrutide apart is its triple action approach. Unlike other medications like semaglutide which only targets GLP-1 receptors, retatrutide works on three types of receptors; GIP, GLP-1, and glucagon. This unique combination helps extend feelings of fullness by slowing down the rate at which the stomach empties after meals. It also helps stabilize blood sugar levels by boosting insulin release and converting excess sugar into glucose.” Your “Semaglutide” and “Retatrutide” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). [B146] 331(d) and 355(a). [B86] 355 are in effect for these products. [B145] 331(d) and 355(a). [B135] [B2] [B20] [B0] [B136] [B139] [B87] [B84] [B118] Your response should be sent to U.S. [B164] Sincerely, /S/ Tina Smith, M.S. Captain, U.S. [B138] 12/17/2024 Regulated Product(s)

#### [9] summit-research-peptides-695607-12102024 | issued 12/10/2024 | Summit Research Peptides | SUBJ: Unapproved New Drugs/Misbranded
WARNING LETTER December 10, 2024 RE: 695607 Dear Summit Research Peptides: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://summitpeptides.shop in October 2024 and has observed that your website offers “Semaglutide” (or “Sema”), “Retatrutide” (or “Reta”), “Cagrilintide,” “Tirzepatide” (or “Tirz”), and “Mazdutide” products for sale in the United States. We have also reviewed your social media website at https://www.facebook.com/summitpeptides/. Your social media website directs consumers to your https://summitpeptides.shop website to purchase your products. As described below, your “Semaglutide” (or “Sema”), “Retatrutide” (or “Reta”), “Cagrilintide,” “Tirzepatide” (or “Tirz”), and “Mazdutide” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Despite statements on your product labeling marketing your products as “RESEARCH USE ONLY” and “INTENDED AS A RESEARCH CHEMICAL ONLY,” evidence obtained from your websites establish that your products are intended to be drugs for human use. [B137] 321(g)(1), because they are intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body. Examples of claims observed on your websites that establish the intended use of your products as drugs intended for human use include, but may not be limited to, the following: From your “Semagultide” (or “Sema”) product webpage https://summitpeptides.shop/products/sema-10-pack?variant=45101962887394: • “Overview: Sema is a GLP-1 analog with therapeutic applications in type 2 diabetes and obesity. It enhances insulin secretion and reduces appetite, leading to improved glycemic control and weight loss.” • “Product Features: o GLP-1 analog simulating human incretin activity o Enhances insulin secretion and beta cell function o Delays gastric emptying, reducing appetite o Supports weight management in obesity o Exhibits cardioprotective and neuroprotective potential” From your “Retatrutide” (or “Reta”) product website https://summitpeptides.shop/products/reta?variant=45843937525986: • “Overview: Reta is an experimental tritagonist drug targeting three hormone receptors: GLP-1, GIP, and glucagon. It is designed to mimic these hormones' effects, such as enhancing satiety, regulating blood sugar, and suppressing appetite.” • “Product Features: o Tritagonist: Interacts with GLP-1, GIP, and glucagon receptors. o Regulates appetite and blood sugar levels. o Administered via specific receptors in the brain and gut.” • “Conclusion: Reta presents a promising approach for obesity and diabetes treatment, offering a novel mechanism of action through a triple-receptor agonist profile. It’s a significant development in the search for more effective treatments for these conditions.” On your social media website at https://www.facebook.com/summitpeptides/: • May 18, 2024 post: “Unlock Maximum Health Benefits with Cagrilintide and Semaglutide . . . designed to help you achieve your health goals more effectively than ever before! Enhanced Weight Loss: Achieve superior weight reduction with the synergistic effects of Cagrilintide and Semaglutide. Experience greater weight loss results and take control of your journey to a healthier you. Optimized Cardiovascular Health: Support your heart health with this powerful combination. Promote better cardiovascular health and ensure your heart remains strong and healthy. Improved Glucose Management: Maintain stable blood sugar levels and achieve effective glucose control with the combined benefits of Cagrilintide and Semaglutide, enhancing your overall metabolic health . . . Achieve Your Weight Loss Goals Faster with Cagrilintide & Semaglutide” From your “Tirzepatide” (or “Tirz”) product website https://summitpeptides.shop/products/tirz?_pos=1&_sid=39f4021bd&_ss=r • “Overview: Tirzepatide is a cutting-edge synthetic derivative of the Glucagon-Like Peptide-1 (GLP-1), designed specifically for the scientific community to advance research in metabolic disorders and diabetes management. With its unique structure and mode of action, Tirz represents a promising frontier for investigating new therapeutic strategies.” • “Research Applications: Tirz is extensively utilized in preclinical studies to explore its potential in: o Enhancing insulin secretion o Regulating blood sugar levels o Investigating weight management pathways o Exploring cardiovascular benefits.” From your “Mazdutide” product website https://summitpeptides.shop/collections/full-catalog/products/mazdutide • “Mazdutide is an investigational peptide with a novel dual-action mechanism, designed to mimic and enhance the biological activities of certain endogenous hormones. It is at the forefront of research in metabolic disorders and has shown promising results in early studies related to weight management and glucose regulation.” • “Mazdutide is primarily investigated for its potential in: o Understanding and enhancing wight loss mechanisms o Improving glucose homeostasis in diabetic models o Studying hormone receptor interactions and signaling pathways o Exploring its effects on metabolic rate and energy expenditure Your “Semaglutide” (or “Sema”), “Retatrutide” (or “Reta”), “Cagrilintide,” “Tirzepatide” (or “Tirz”), and “Mazdutide” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). [B146] 331(d) and 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. [B145] 331(d) and 355(a). [B135] [B2] [B20] [B0] [B136] Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. [B87] [B84] [B118] Your response should be sent to U.S. [B164] Sincerely, /S/ Tina Smith, M.S. Captain, U.S. [B138] 12/17/2024 Regulated Product(s)

#### [10] swisschems-695663-12102024 | issued 12/10/2024 | Swisschems | SUBJ: Unapproved New Drugs/Misbranded
WARNING LETTER December 10, 2024 Dear Swisschems: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://swisschems.is/ in October 2024 and has observed that your website offers “Semaglutide” and “Retatrutide” products for sale in the United States. We have also reviewed your Facebook social media website at https://www.facebook.com/swisschems.is/ and your Instagram social media website at https://www.instagram.com/swisschemsupgraded where you direct consumers to your websites at https://swisschems.is/ to purchase your products. As described below, your “Semaglutide” and “Retatrutide” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Despite statements on your product labeling marketing your products as “research chemicals only,” evidence obtained from your website establishes that your products are intended to be drugs for human use. [B137] [B163] [B243] Semaglutide On the product webpage for “Semaglutide,” https://swisschems.is/product/semaglutide-3mg-1-vial/: • “Peer-Reviewed Studies . . . Once-weekly semaglutide in adults with overweight or obesity. . .. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes.” On a September 18, 2024, post from your Facebook social media website, https://www.facebook.com/swisschems.is/ and your Instagram social media website, https://www.instagram.com/swisschemsupgraded: • “Ready to elevate your research? Semaglutide, a key player in metabolic and weight regulation is now available! Don’t miss this chance to explore its role in glucose regulation, energy balance, and more. . .. Special Offer: Buy 3 or more and get 10% OFF your order! Stock up now for your next breakthrough. #Semaglutide #MetabolicStudies . . . #GlucoseRegulation” Retatrutide On the product webpage “Retatrutide,” https://swisschems.is/product/retatrutide-5mg/: • “Retatrutide (LY-3437943) is a promising anti-obesity agent. It is designed to be a triple hormone receptor agonist, meaning it activates three important receptors in the body: GLP-1 (glucagon-like peptide-1), GIP (glucose-dependent insulinotropic polypeptide), and GCGR (glucagon receptor). These receptors play crucial roles in regulating glucose levels and metabolic functions in the body.” • “Peer-Reviewed Studies . . . Triple-Hormone-Receptor Agonist Retatrutide for Obesity – A Phase 2 Trial . . . Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA” Your “Semaglutide” and “Retatrutide” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). [B146] 331(d) and 355(a). [B86] 355 are in effect for these products. [B145] 331(d) and 355(a). [B135] [B2] [B20] [B0] [B136] Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. [B87] [B84] [B118] Your response should be sent to U.S. [B164] Sincerely, /s/ Tina Smith, M.S Captain, U.S Public Health Service Director Office of Unapproved Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research Food and Drug Administration Content current as of: 12/17/2024 Regulated Product(s)

#### [11] veronvy-694688-12102024 | issued 12/10/2024 | Veronvy | SUBJ: Unapproved New Drugs/Misbranded
WARNING LETTER December 10, 2024 RE: 694688 Dear Veronvy: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.veronvy.com/ in October 2024 and has observed that your website offers “Elily Veronvy” and “Elily Veronvy 40+” products for sale in the United States. As described below, your “Elily Veronvy” and “Elily Veronvy 40+” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, “Elily Veronvy” and “Elily Veronvy 40+” are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. [B241] 331(a). Unapproved New Drugs Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. [B163] [B243] Elily Veronvy and Elily Veronvy 40+ From your webpage https://www.veronvy.com/products/veronvy: • “Veronvy Metabolic Boost Drops successfully helped people lose up to 52 pounds in 3 months during clinical trials and was approved by the Food and Drug Administration last year.” • “Metabolism boost drops for weight management.” • “The Science of GLP-1 . . . The effectiveness of the Veronvy Metabolic Boost Drops lies in its dual-action approach, addressing intake and expenditure. On one hand, it suppresses appetite, aiding in reduced food consumption and subsequent weight loss. It also slows gastric emptying, prolonging the feeling of fullness over an extended period. On the other hand, it accelerates the body's metabolism, promoting fat burning.” On your webpage “Why Veronvy?,” https://www.veronvy.com/pages/why-veronvy%C2%AE: • “You may have attempted to lose weight and keep it off many times in the past. The ups and downs can certainly be difficult, but you may finally be able to lose weight and keep it off with the help of Veronvy. . .. While taking Veronvy, people not only lost weight only lot weight [sic], but also kept it off[.] In addition to a reduced-calorie diet and increased physical activity, people in this study taking Veronvy lost more weight vs placebo” Your “Elily Veronvy” and “Elily Veronvy 40+” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). [B146] 331(d) and 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. [B145] 331(d) and 355(a). Misbranded Drugs Your “Elily Veronvy” and “Elily Veronvy 40+” products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the product labels and/or websites include statements that misleadingly suggest that the drug products are approved or endorsed by FDA in some way. For example: the webpage for “Elily Veronvy” and “Elily Veronvy 40+” includes the image of a blue circle with the claim, “FDA APPROVED” along with the statement, “Veronvy Metabolic Boost Drops . . . was approved by the Food and Drug Administration last year.” As previously noted, there are no FDA-approved applications in effect for your “Elily Veronvy” and “Elily Veronvy 40+” products. Therefore, these products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because their labeling is false or misleading. The introduction or delivery for introduction into interstate commerce of these misbranded drugs are a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). [B135] [B2] [B20] [B0] [B136] [B139] [B87] [B84] [B118] Your response should be sent to U.S. [B164] Sincerely, /S/ Tina Smith, M.S. Captain, U.S. Public Health Service Director Office of Unapproved Drugs & Labeling Compliance Office of Compliance Center for Drug Evaluation and Research U.S. [B247] 12/17/2024 Regulated Product(s)

#### [12] xcel-research-llc-694608-12102024 | issued 12/10/2024 | Xcel Research LLC | SUBJ: Unapproved New Drugs/Misbranded
WARNING LETTER December 10, 2024 RE: 694608 Dear Andrew Pierce: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://www.xcelpeptides.com in October 2024 and has observed that your website offers various products such as “RETA” (Retatrutide), “CagriLean” (Cagrilintide and Semaglutide), “CAGRILINTIDE,” “MAZDUTIDE,” “SEMA” (Semaglutide), “SURVODUTIDE,” and “SERMORELIN,” for sale in the United States. As described below, your “RETA” (Retatrutide), “CagriLean” (Cagrilintide and Semaglutide), “CAGRILINTIDE,” “MAZDUTIDE,” “SEMA” (Semaglutide), “SURVODUTIDE,” and “SERMORELIN,” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Despite statements on your product labeling marketing your products, “FOR RESEARCH USE ONLY” and “NOT INTENDED FOR HUMAN USE,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21 U.S.C. [B163] [B243] “RETA” (Retatrutide) On your webpage https://www.xcelpeptides.com/product/reta/: • “Retatrutide, a triple agonist peptide, interacts with glucagon, GIP, and GLP-1 receptors. In clinical trials, it exhibits potential for weight management by regulating appetite and metabolism in research test subjects.” • “Enhanced Insulin Sensitivity . . . By enhancing insulin sensitivity, retatrutide peptide helps test subjects maintain stable blood glucose levels and reduces the risk of developing metabolic disorders associated with insulin resistance.” • “Cardiovascular Protection . . . [R]etatrutide peptide has been shown to improve endothelial function, reduce arterial stiffness, and lower blood pressure, thus reducing the risk of cardiovascular diseases such as hypertension and atherosclerosis.” “CagriLean” (Cagrilintide and Semaglutide) On your webpage https://www.xcelpeptides.com/product/cagrilean/: • “Cagrilintide and semaglutide blend that aids test subjects in managing weight and improving blood sugar levels. This peptide combination helps research subjects feel fuller for longer, curbing their appetite and enhancing metabolic function.” • “Understanding Cagrilintide and Semaglutide . . . Cagrilintide is a synthetic peptide known for its ability to regulate appetite. It mimics the natural hormone amylin, which plays a crucial role in controlling hunger and food intake. On the other hand, Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. It has been extensively researched for its effects on glucose regulation and appetite suppression.” • “Enhanced Glucose Regulation . . . CagriLean helps maintain stable blood glucose levels, reducing the risk of glucose spikes and crashes. This can be instrumental in experiments focusing on insulin sensitivity, glucose metabolism, and the development of diabetes treatments.” “CAGRILINTIDE” On your webpage https://www.xcelpeptides.com/product/cagrilintide/: • “Enhanced Glucose Control . . . By influencing the release of insulin and other hormones involved in glucose metabolism, it may help stabilize blood sugar levels. This effect could be beneficial for research test subjects with conditions such as diabetes or insulin resistance.” • “Improved Lipid Profile: Research suggests that Cagrilintide may also have favorable effects on lipid metabolism, leading to improvements in lipid profiles. By influencing the breakdown and utilization of fats, it may help lower levels of triglycerides and LDL cholesterol while increasing HDL cholesterol levels.” • “Cagrilintide exhibits a wide range of potential health benefits for research test subjects, spanning appetite regulation, glucose control, weight management, lipid metabolism, inflammation, cardiometabolic protection, neuroprotection, and the convenience of long-acting formulation.” “MAZDUTIDE” On your webpage https://www.xcelpeptides.com/product/mazdutide/: • “Mazdutide. . .[is] designed to mimic the actions of a hormone called glucagon-like peptide-1 (GLP-1). It offers numerous benefits in research subjects, such as improving blood sugar control by stimulating insulin secretion and reducing appetite. Additionally, it aids in weight management and may enhance cardiovascular health by lowering blood pressure and improving cholesterol levels.” • “Cardiovascular Health: Mazdutide exhibits cardioprotective effects, which could be advantageous for research test subjects at risk of cardiovascular diseases. GLP-1 receptor activation has been linked to improvements in cardiovascular function, such as reducing blood pressure and improving lipid profiles.” “SEMA” (Semaglutide) On your webpage https://www.xcelpeptides.com/product/sema/: • “Regulation of Blood Sugar Levels: Sema exhibits potent glucose-lowering effects by stimulating insulin secretion and inhibiting glucagon release, two crucial mechanisms in maintaining blood sugar balance.” • “Weight Loss and Appetite Suppression: . . . By acting on specific receptors in the brain, this peptide promotes satiety and reduces food intake, leading to decreased body weight and fat mass.” • “Neuroprotective Potential: Emerging evidence suggests that semaglutide peptide may possess neuroprotective properties, offering potential benefits in neurodegenerative diseases such as Alzheimer’s disease.” “SURVODUTIDE” On your webpage https://www.xcelpeptides.com/product/survodutide/: • “Survodutide. . .belongs to a class of drugs known as dual agonists, meaning it targets two different types of receptors in the body: the glucagon receptor and the glucagon-like peptide-1 (GLP-1) receptor. These receptors play crucial roles in regulating various bodily functions, including metabolism, appetite, and blood sugar levels.” • “Health Benefits of Survodutide . . . Improved Blood Sugar Control[.] One of the most significant benefits of survodutide is its ability to improve blood sugar control in research lab subjects . . .. [I]t can help regulate blood glucose levels more effectively than targeting either receptor alone. In research subjects, this dual action has shown promise in stabilizing blood sugar levels, which is crucial for managing conditions like diabetes." “SERMORELIN” On your webpage https://www.xcelpeptides.com/product/sermorelin/: • “Sermorelin, a peptide studied in clinical trials, is believed to enhance the release of growth hormone in subjects. This heightened growth hormone production is associated with potential benefits, including improved metabolism and the facilitation of weight loss.” • “Enhanced Muscle Growth and Repair[.] One of the primary benefits observed in test subjects administered with sermorelin is enhanced muscle growth and repair.” • “Improved Metabolism and Fat Loss[.] Another notable benefit of sermorelin is its potential to improve metabolism and aid in fat loss.” Your “RETA” (Retatrutide), “CagriLean” (Cagrilintide and Semaglutide), “CAGRILINTIDE,” “MAZDUTIDE,” “SEMA” (Semaglutide), “SURVODUTIDE,” and “SERMORELIN” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). [B146] 331(d) and 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. [B145] 331(d) and 355(a). [B135] [B2] [B20] [B0] [B136] Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. [B87] [B84] If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. [B147] Sincerely, /S/ Tina Smith, M.S. Captain, U.S. [B138] 12/17/2024 Regulated Product(s)

#### [13] wwwweightcrunchshopcom-695815-01132025 | issued 01/13/2025 | www.weightcrunchshop.com | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
WARNING LETTER This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.weightcrunchshop.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)]. As discussed below, FDA has observed that www.weightcrunchshop.com introduces into interstate commerce unapproved and misbranded semaglutide and opioid drug products. [B110] [B90] [B91] Accordingly, FDA requests that www.weightcrunchshop.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to protect the public from harm. Unapproved New Drugs: Certain products offered for sale by www.weightcrunchshop.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. [B109] [B100] [B98] [B97] For example, www.weightcrunchshop.com offers semaglutide drug products marketed as “Orsema 0.25 mg” injectable and “Orsema 0.50 mg” injectable. Your website states that the product is intended as, “An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus,” and “To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.” While there are FDA-approved versions of semaglutide on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Orsema 0.25 mg” or “Orsema 0.50 mg” offered by www.weightcrunchshop.com. Currently, there are two injectable semaglutide products FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. [B161] [B246] [B162] [B116] Misbranded Drugs: [B101] “Adequate directions for use,” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). [B214] [B213] Because “Orsema 0.25 mg” and “Orsema 0.50 mg” are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for the intended use. Consequently, the labeling for the drugs fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. [B133] By offering these drugs for sale to U.S. consumers, www.weightcrunchshop.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. Additionally, FDA has observed that www.weightcrunchshop.com offers prescription drugs for sale without a prescription. For example, your website offers semaglutide drug products marketed as “Ozempic 0.25 mg,” “Ozempic 0.5 mg,” and “Ozempic 1 mg.” Your website states, “Ozempic is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Buy Ozempic Online without Prescription with Credit Card.” Ozempic is the brand name of an FDA-approved drug for the treatment of type 2 diabetes mellitus and established cardiovascular disease that is only available by prescription. Using the brand name of the drug product Ozempic indicates that this product is intended to treat type 2 diabetes mellitus and established cardiovascular disease. The FDA-approved product Ozempic has been approved for marketing by FDA and is limited by a new drug application to use under the supervision of a practitioner licensed to administer such drugs. Therefore, Ozempic is a prescription drug as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. § 353(b)(1)(A)). Furthermore, www.weightcrunchshop.com offers oxycodone 15 mg and 30 mg tablets described as “moderately potent opioid analgesic, generally indicated for the relief of moderate to severe pain.” Your website, www.weightcrunchshop.com also states that “oxycodone is for sale without a prescription.” FDA-approved oxycodone is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate and is only available pursuant to a prescription from a licensed practitioner. FDA-approved oxycodone products bear a boxed warning that addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when oxycodone is taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death. [B248] By offering the aforementioned drugs without requiring a prescription, www.weightcrunchshop.com jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act. [B134] FDA is sending this warning letter to www.weightcrunchshop.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. [B96] [B94] [B93] [B132] [B103] [B104] [B125] [B102] [B83] [B99] [B81] [B95] [B117] Sincerely, /S/ S. Leigh Verbois, Ph.D. [B212] 01/21/2025 Regulated Product(s)

#### [14] usapeptidecom-696885-02262025 | issued 02/26/2025 | USApeptide.com | SUBJ: Unapproved New Drugs/Misbranded
WARNING LETTER This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.usapeptide.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)]. As discussed below, FDA has observed that www.usapeptide.com introduces into interstate commerce unapproved and misbranded semaglutide and tirzepatide drug products. [B110] [B90] [B91] Accordingly, FDA requests that www.usapeptide.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to protect the public from harm. Unapproved New Drugs: Despite statements on your product labeling and website such as “research use only,” “not for human consumption,” “lab purposes only,” and “not intended to diagnose, cure, mitigate, treat or prevent disease,” evidence obtained from your website establishes that certain products offered for sale by www.usapeptide.com are drugs intended for human use. Examples of claims from the products’ labeling, including on your website listed above, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs for human use includes the following: Semaglutide (GLP-1 Analogue) 5mg and Semaglutide (GLP-1 Analogue) 10mg: “Semaglutide, also marketed under the brand names Ozempic, Rybelsus and Wegovy, is an FDA-approved injectable for weight loss…” “Semaglutide is a potent once-weekly GLP-1 RA, significantly reducing HbA1c, body weight and systolic blood pressure.” 5mg Tirzepatide (Mounjaro) 5mg and 10mg Tirzepatide (Mounjaro) 10mg: “… recently approved in the US to help type 2 diabetes patients better manage blood sugar.” “Tirzepatide is a compound that has been shown to help with weight loss…” “… stimulates the release of hormones that signal the brain to reduce food intake and increase feelings of fullness.” These products are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. [B109] [B100] [B98] [B97] On www.usapeptide.com, you offer semaglutide marketed as “Semaglutide (GLP-1 Analogue) 5mg” and “Semaglutide (GLP-1 Analogue) 10mg.” While there are FDA-approved versions of semaglutide on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Semaglutide (GLP-1 Analogue) 5mg” and “Semaglutide (GLP-1 Analogue) 10mg” offered by www.usapeptide.com. [B165] [B161] [B246] FDA-approved semaglutide tablets marketed under the brand name Rybelsus are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [B162] [B116] In addition, on www.usapeptide.com you offer tirzepatide marketed as “5mg Tirzepatide (Mounjaro) 5mg” and “10mg Tirzepatide (Mounjaro) 10mg.” While there are FDA-approved tirzepatide products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the 5mg Tirzepatide (Mounjaro) 5mg” and “10mg Tirzepatide (Mounjaro) 10mg” offered by www.usapeptide.com. Currently there are two tirzepatide products that are FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved tirzepatide injection marketed under the brand name Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. FDA-approved tirzepatide injection marketed under the brand name Zepbound is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in certain adult patients. FDA-approved tirzepatide also bears a boxed warning addressing the risk of thyroid C-Cell tumors. Misbranded Drugs: [B101] [B108] [B143] [B144] [B124] [B142] [B133] By offering these drugs for sale to U.S. consumers, www.usapeptide.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. Additionally, “Semaglutide (GLP-1 Analogue) 5mg,” “Semaglutide (GLP-1 Analogue) 10mg,” “5mg Tirzepatide (Mounjaro) 5mg,” and “10mg Tirzepatide (Mounjaro) 10mg” offered by www.usapeptide.com are intended for injection, which heightens the public health concern associated with these products and may further contribute to the potential for patient harm. On www.usapeptide.com you offer “Bacteriostatic Water 20ml Vial” and “10 PACK OF INSULIN SYRINGES ASST. SIZES.” [B131] [B240] By offering the aforementioned drugs without requiring a prescription, www.usapeptide.com jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act. [B134] FDA is sending this warning letter to www.usapeptide.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. [B96] [B94] [B93] [B132] [B103] [B104] [B125] [B102] [B83] [B99] [B81] [B95] [B117] Sincerely, /S/ S. Leigh Verbois, Ph.D. [B212] 03/11/2025 Regulated Product(s)

#### [15] prorx-llc-696742-03042025 | issued 03/04/2025 | ProRx, LLC | SUBJ: Compounding Pharmacy/Adulterated Drug Products
WARNING LETTER WL # 696742 March 4, 2025 Dear Mr. L’Hommedieu: You registered your facility with the U.S. [B181] 2 on April 27, 2022, and most recently on November 22, 2024. From July 15, 2024, to August 2, 2024, FDA investigators inspected your facility, ProRx, LLC, located at 619 Jeffers Circle, Exton, Pennsylvania 19341. During the inspection, the investigators collected evidence that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA. In addition, the investigators noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk. FDA issued a Form FDA 483 to your facility on August 2, 2024. FDA acknowledges receipt of your facility’s responses, dated August 7, 2024, August 23, 2024, and September 18, 2024. FDA acknowledges that your firm ceased sterile drug production as of August 7, 2024, and notified FDA, on November 11, 2024, of an intent to resume sterile drug production. FDA also acknowledges that on August 22, 2024, your firm initiated a voluntary recall of drug products intended or expected to be sterile, within expiry, due to lack of sterility assurance. [B176] A. [B168] [B106] 3 An outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; [B182] [B174] [B184] In addition, for a drug product compounded using bulk drug substances to qualify for exemptions under section 503B, each bulk drug substance used to compound a drug product must be manufactured by an establishment that is registered under section 510 of the FDCA [21 U.S.C § 360] (section 503B(a)(2)(C) of the FDCA [21 U.S.C. § 353b(a)(2)(C)]). In addition, for a compounded drug product to qualify for the exemptions under section 503B, the labeling of the drug must include certain information (section 503B(a)(10) of the FDCA [21 U.S.C. §353b(a)(10)]). Furthermore, for a compounded drug product to qualify for the exemptions under section 503B, it must be compounded in an outsourcing facility that is in compliance with the registration and reporting requirements in section 503B(b), including the requirement to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations)” [B172] B. Failure to Meet the Conditions of Section 503B During the inspection, FDA investigators noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigators collected evidence that: 1. Your facility compounded drug products using a bulk drug substance from (b)(4) , which is not a registered establishment under section 510 of the FDCA. 2. Your facility’s drug products, such as Semaglutide 5mg/2ml (2.5mg/ml) 2ml, Tirzepatide 60mg/3ml (20mg/ml) 3ml, and Vancomycin 25mg/ml 10ml, did not include the following on the label: the statement “This is a compounded drug”; the name, address, and phone number of the applicable outsourcing facility; the established name of the drug; the dosage form; the statement “Office Use Only”; and a list of active and inactive ingredients, identified by established name and the quantity and proportion of each ingredient. 3. Your facility’s drug products, such as Vancomycin 25mg/ml 10ml, and Tobramycin 14mg/ml 10ml, did not include the following information on the container: 1) information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088 and 2) directions for use, including, as appropriate, dosage and administration. 4. [B218] Specifically, your facility’s procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events (1) do not include a definition of what constitutes a “serious” and “unexpected” adverse event (21 CFR 310.305(b)); (2) do not include a requirement to report each adverse drug experience received or otherwise obtained that is both serious and unexpected as soon as possible, but in no case later than 15 calendar days of initial receipt of the information (21 CFR 310.305(c)(1)(i)); (3) do not include a requirement to promptly investigate and submit a follow-up report regarding a serious, unexpected adverse event within 15 calendar days of receipt of new information or as requested by FDA (21 CFR 310.305(c)(2)); (4) do not include a requirement that the firm investigate four data elements when an adverse event report is received – Identifiable Patient, Identifiable Reporter, Suspect Drug Product, Serious Adverse Event (21 CFR 310.305(d)); and (5) do not provide that adverse events should be reported utilizing FDA’s Safety Reporting Portal (SRP) or Electronic Submission Gateway (ESG) (21 CFR 310.305(e)). 4 Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA. Specific violations are described below. C. Violations of the FDCA Adulterated Drug Products FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigators observed that: 1. Your firm’s operator was observed filling drug product intended to be sterile in a manner that directly blocked first pass air over uncapped filled vials. 2. Your firm’s Pharmacist in Charge (PIC) was observed rapidly prodding a pile of sterilized rubber caps with forceps, in an attempt to dislodge them, inside of the ISO 5 Biosafety Cabinet (BSC), near uncapped filled vials of drug product intended to be sterile. This practice, moving quickly in a critical area, may disrupt airflow and increases the risk of bringing lesser quality air into the ISO 5 area. 3. An operator exposed their bare hands within the ISO 5 work area while donning gloves in preparation for aseptic production. 4. Your firm’s PIC put on gowning apparel in a way that may cause the gowning apparel to become contaminated. Specifically, your firm’s PIC was observed bending down on the floor, on their hands and knees, inside of the ISO 7 Anteroom. Your firm’s PIC then only sprayed their gloves with (b)(4) and proceeded to produce drug products intended to be sterile. 5. Your firm’s ISO 5 BSC is powered off when not in use and during the cleaning and disinfection process prior to aseptic drug production. There is no assurance that contamination is not introduced when the BSC is powered off as it may allow for the influx of lesser quality air into a higher quality air area. 6. Your firm used non-sterile wipes within the ISO 5 aseptic processing area. 7. Your media fills were not performed under the most challenging or stressful conditions. [B249] 8. Your firm has never performed environmental monitoring in the ISO 5 area. 9. [B219] [B148] 10. A flying insect was observed on the walls and ceilings of the ISO 7 Anteroom and on the door inside of the ISO 7 Buffer Room, approximately 10 feet from the ISO 5 BSC used for sterile drug processing. FDA investigators also noted CGMP violations at your facility, that caused your drug product(s) to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example: 1. [B183] 2. [B216] 3. Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)). 4. [B215] 5. Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)). 6. Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)). 7. Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition (21 CFR 211.56(a)). 8. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63). 9. Your firm failed to establish an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). 10. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). [B178] [B169] [B180] [B173] [B177] [B151] [B140] [B179] 5 Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 331(d)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. [B105] [B220] [B217] [B170] [B167] D. Corrective Actions We have reviewed your facility’s responses to the Form FDA 483. FDA acknowledges that your firm ceased sterile drug production as of August 7, 2024, and notified FDA, on November 11, 2024, of an intent to resume sterile drug production. FDA also acknowledges your voluntary recall, on August 22, 2024, of drug products intended or expected to be sterile, within expiry, due to lack of sterility assurance. We are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation: 1. Regarding your media fills, we acknowledge your commitments described in your response, including that you have revised your media fill SOP and that, “Going forward, the size and scope of media fill will be (b)(4) .” However, to date, you have not submitted the revised media fill SOP, training records, or any other supporting documentation to demonstrate that the corrective actions were implemented. You have submitted two blank documents that appear to be your media fill batch record templates with no specific details reflecting the commitments written in your response. Moreover, your firm has provided no justification for failing to conduct an investigation and implement corrective and preventive actions (CAPA) related to your failed media fill. Any contaminated unit should be considered objectionable and investigated. Whenever contamination exists in a media fill batch, it should be considered indicative of a potential sterility assurance problem. 2. Regarding your failure to establish a pest control program, you stated that you have instituted a formalized pest control policy and have signed a contract with (b)(4) to assist with (b)(4) monitoring of the perimeter of your facility and inside areas as needed. However, it appears your firm has not conducted any investigation to identify the root cause, specifically, where and how these insects enter the facility, or taken appropriate action to eliminate these points of ingress. Some of your corrective actions appear deficient: 1. The process outlined in your SOP #: ProSOP-B094 Rev.00, allows for the use of a sterile (b)(4) to cover unfilled sterile vials and directs operators to move the (b)(4) during filling. This practice puts the product at risk for contamination and may also disrupt unidirectional airflow to the exposed produc t. 2. The process outlined in your SOP #: ProSOP-B088, Rev. 00, instructs operators to don their (b)(4) of sterile gloves after donning not only their hair net, facemask, and shoe covers, but also the sterile garment using their bare hands. While the procedure requires your operator to wash and clean their hands with antiseptic before gowning, gowning with bare hands compromises the sterile garment and represents a contamination risk to your aseptic production environment. Additionally, your gowning procedure permits the reuse of gowning multiple times after entry and exit of the cleanroom within the same compounding day, which also represents a contamination ris k. 3. The procedure outlined in your SOP #: ProSOP-B090, Rev. 00, appears contradictory. Step 7.1.4 within the SOP, states that the BSC (b)(4) . However, the instruction in step 7.1.5 states to turn off the blower prior to and during the sanitization of the BSC. You did not provide any scientific justification or data to support this practic e. 4. The supporting document you provided in your response does not adequately demonstrate that your cleanrooms were certified under dynamic conditions. For example, on page 8 of 12, the certification report indicates the room’s status as “At Rest” and the number of people in room is “ (b)(4) .” This does not appear to represent dynamic conditions at your facility. Review of the evidence collected during the inspection notes that your production process for sterile filling requires (b)(4) operators in the BSC during filling and capping. 5. In your response, you stated that you, “purchased media that came with a valid Certificate of Analysis (COA)” and that “the COA lists all the organisms that the media supports.” Your response is not adequate as the media your firm uses is not a ready-to-use media; it comes in (b)(4) form that requires additional preparation at your facility before it can be used as intended. You did not commit to conducting growth promotion testing after media preparation to ensure that the media was prepared correctly prior to use. Growth promotion testing should be performed on all lots of prepared media. 6. Regarding your Environmental Monitoring (EM) and Personnel Monitoring (PM), we acknowledge your commitment to include EM/PM for all your future batches and to also incubate your sampling plates at (b)(4) temperatures. However, you have not provided sufficient details regarding your planned corrective actions. In addition, you did not commit to revising the action level (“ (b)(4) ”) for viable surface sampling within the ISO 5 environment. Any microbial contamination within the ISO 5 area is a serious concern, and upon recovery, your firm should immediately assess the impact on drug products produced. This assessment should include a thorough evaluation of how contamination could have entered this critical area, and the time period over which the contamination could have existed, as well as an evaluation of drug products that remain on the market that could be affected. 7. In response to our concerns with your smoke studies, you provided a new smoke study conducted on August 13, 2024. However, this smoke study does not appear to be a simulation of operational conditions at your facility. For example, it does not include all materials and equipment your firm uses during production, such as IV bag setup and aseptic filling. 8. Regarding the lack of a defined minimum pressure differential between classified and non-classified spaces, you stated that you have revised your SOP to define the pressure differential from the ISO 7 space to the non-classified area to (b)(4) . However, you did not provide scientific justification for utilizing this specification. A positive pressure differential of at least 0.04-0.06 inches of water gauge (10-15 Pascals (Pa)) should be maintained between adjacent rooms of differing classification (with doors closed). 9. Regarding our concerns noted with your visual inspection program, we acknowledge you established a written procedure for your visual inspection process, SOP #: ProSOP-B069, Rev. 00. However, your SOP lacks key procedures and processes required for a visual inspection program. For example, there was no mention of 100% inspection, Acceptance Quality Limit (AQL) inspection, operator qualification, classification of defects, or the testing environment. Additionally, there is no scientific justification for how your PIC is going to assess, “the integrity and quality of the preparation” with respect to your new SOP stating to notify the PIC if there was a discrepancy observed during visual inspection and the PIC will, “decide on the integrity and quality of the preparation.” 10. Regarding your failure to perform a disinfectant efficacy study, your responses focus on purchasing ready to use pharmaceutical grade germicidal detergents, disinfectants, and (b)(4) sporicidal solutions and a commitment to use them per the manufacturer’s instructions. While your firm may rely on this information when initially determining the effectiveness of agents used to clean and disinfect, your firm still needs to conduct an evaluation of the suitability and efficacy of the cleaning agents and cleaning methods with applicable work surfaces within your facility. 11. Your responses related to your equipment qualification studies are not adequate. For example, you did not perform an adequate load study on any of the listed units within this observation. All the units were tested via a mapping study on “empty shelves.” You did not test these units under the load comparable to that expected during routine production. There was no information describing the different type of materials (e.g., vials, caps, rubber stoppers) that were loaded inside these units to represent routine production. You did not establish any preventative maintenance requirements for any of the equipment listed within this observation with the exception of the (b)(4) unit. You did not provide any scientific justification for your statement that these units, that are used for testing and storage of your sterile drug products, are all “maintenance free except when poor temperature control is observed” then an investigation will be open and “rectified by appropriate repair.” [B175] See section 501 of the FDCA. [B154] [B152] [See 21 CFR 210.1(b), 21 CFR 200.10(b).] Regarding observations related to the conditions of section 503B of the FDCA, your corrective actions appear deficient: 1. The information that you submitted, including the SOP for Product Labeling and the Label Template, does not adequately address the labeling deficiencies. Specifically, the label template does not provide for a list of active ingredients, identified by established name and the quantity or proportion of each ingredient. 2. Your revised documented procedures for reporting adverse events do not adequately address adverse event reporting. For example: a. Your procedures do not adequately define what constitutes a “serious” and “unexpected” adverse event; b. Your procedures do not include a requirement to report each adverse drug experience received or otherwise obtained that is both serious and unexpected as soon as possible, but in no case later than 15 calendar days of initial receipt of the information; c. Your procedures do not include a requirement to promptly investigate and submit a follow-up report regarding a serious, unexpected adverse event within 15 calendar days of receipt of new information or as requested by FDA; d. Your procedures do not include a requirement that the firm investigate four data elements when an adverse event report is received – Identifiable Patient, Identifiable Reporter, Suspect Drug Product, Serious Adverse Event; and e. Your procedures do not provide that adverse events should be reported utilizing the Safety Reporting Portal (SRP) or Electronic Submission Gateway (ESG). Furthermore, you have not addressed the compounding of drug products using bulk drug substances manufactured by establishments which are not registered establishments under section 510 of the FDCA. [B171] [B150] In particular, this review should assess your aseptic processing operations and CGMP compliance. [B250] Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. [B245] E. [B126] [B2] [B20] [B153] [B1] [B166] [B17] [B0] [B16] [B4] [B251] In your response, refer to the Warning Letter Number above (#696742) and include a subject line that clearly identifies the submission as a Response to Warning Letter. Sincerely, /S/ F. Gail Bormel, JD, RPh Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ___________ 1 The Amended Warning Letter includes changes to the date of the letter and the named addressee as well as to the title of the letter. The original Warning Letter was issued to an individual who was no longer employed by the firm at the time of issuance, and a new responsible individual has been identified. No other material changes were made to the amended letter. For FDA tracking purposes, the original Warning Letter date of December 20, 2024, continues to serve as the date of issuance. 2 See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013). [B149] 4 For more information, see, FDA’s guidance, “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which can be found at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434188.pdf. 5 The specific products made by your firm are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B5] 6 Your compounded drug products are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115). Content current as of: 03/04/2025 Regulated Product(s)

#### [16] tailstorm-health-inc-dba-medivant-health-703497-04082025 | issued 04/08/2025 | Tailstorm Health Inc. dba Medivant Health | SUBJ: Compounding Pharmacy/Adulterated Drug Products
WARNING LETTER WL # 703497 April 8, 2025 Dear Mr. Gandhi: You registered your facility with the U.S. [B181] 1 on October 23, 2019, and most recently on December 18, 2024. From September 24, 2024, to October 10, 2024, an FDA investigator inspected your facility, Tailstorm Health Inc. dba Medivant Health located at 24416 N. 19th Avenue Suite 200, Phoenix, AZ 85085. During the inspection, the investigator collected evidence that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA. In addition, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk. FDA issued a Form FDA 483 and an amended Form FDA 483 to your facility on October 10, 2024. FDA acknowledges receipt of your facility’s responses, dated October 31, 2024, December 9, 2024, and January 23, 2025. FDA also acknowledges that on November 6, 2024, your firm initiated a voluntary recall of lots D24005, D24006, D24007, D24008, D24009, and D24012 of Bevacizumab (Avastin) 1.25mg/0.05mL, 0.5 mL Single-Dose Syringe, intended or expected to be sterile, within expiry, due to lack of sterility assurance. [B176] A. [B168] [B106] [B221] [B182] [B174] [B184] In addition, for a compounded drug product to qualify for the exemptions under section 503B, the labeling of the drug must include certain information (section 503B(a)(10) of the FDCA [21 U.S.C. § 353b(a)(10)]). Furthermore, for a compounded drug product to qualify for the exemptions under section 503B, it must be compounded in an outsourcing facility that is in compliance with the registration and reporting requirements in section 503B(b), including the requirement to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations)” [B172] B. Failure to Meet the Conditions of Section 503B During the inspection, the FDA investigator noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigator collected evidence that: 1. Your facility’s drug products, such as Semaglutide Injection 1mg/0.2ml and Tirzepatide Injection 2.5mg/0.5ml, did not include the following on the label: “Office Use Only.” 2. [B218] Specifically, your facility’s procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events do not describe an adverse event as “unexpected” when one is not listed in the current labeling for the drug product (21 CFR 310.305(b) and do not provide that adverse events should be reported utilizing FDA’s Safety Reporting Portal (SRP) or Electronic Submission Gateway (ESG) (21 CFR 310.305(e)). 3 Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA. Specific violations are described below. C. [B252] For example, the investigator observed that: 1. You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area. 2. [B219] [B148] The FDA investigator also noted CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example: 1. [B215] 2. [B216] [B178] [B169] [B180] [B173] [B177] Under section 301(a) of the FDCA [21 U.S.C. § 331(a), the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. [B140] [B179] 4 Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 331(d)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. [B105] [B220] [B217] 5 The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA. [B167] D. Corrective Actions We have reviewed your facility’s responses to the Form FDA 483. We also acknowledge your recall of lots D24005, D24006, D24007, D24008, D24009, and D24012 of repackaged Bevacizumab (Avastin) 1.25mg/0.05mL, 0.5 mL Single-Dose Syringe, intended or expected to be sterile, within expiry, due to lack of sterility assurance. Regarding your responses related to the insanitary conditions and CGMP violations, some of your proposed corrective actions appear adequate; however, we are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation: 1. Regarding particulate matter testing of your finished drug products: a. We have reviewed your document titled, “Retrospective Review Investigation of Reported OOS incidents (1B).” Within that document, you state, “Tailstorm has researched the product Avastin, which contains Bevacizumab, a protein that may interfere with liquid-borne particle count testing. The nature of the product can lead to inconsistent results when tested microscopically using Method (b)(4) .” You also stated that, “The test method and procedure were found to involve many physical maneuvers” and that, “the preliminary sample preparation steps are not protected under a bio-safety cabinet/LAF (laminar air flow).” Despite these concerns, your firm relied on passing results via method (b)(4) to release lots D24006, D24007, and D24009. b. Your response did not address the approval process for changes occurring at your contract testing facility. FDA is aware that many drug manufacturers use independent contractors such as testing laboratories. FDA regards contractors as extensions of the manufacturer. You are responsible for the quality of your drugs regardless of agreements in place with your contract facility. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contract-manufacturing-arrangements-drugs-quality-agreements-guidance-industry. c. For Bevacizumab lot D24008, your investigation identified elastomer/rubber particles and noted, “source is syringe stopper or syringe cap rubber seal.” However, you did not provide the actions you took to correct and prevent the recurrence of these particles. Your action plans should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, corrective action and preventive action (CAPA) effectiveness, and quality assurance oversight. Some of your corrective actions appear deficient: 1. Regarding your updated smoke studies provided in your response: a. The dynamic smoke study in your video titled “Removal of (b)(4) layer from the tub” under file name “Act 21” does not show smoke in the area in which the open tub of what appears to be product syringes is moved during time 00:51 to 00:58. This same area shows air turbulence during your static smoke study video “ (b)(4) Removal” under file name “Act (b)(4) ” during time (b)(4) . b. The smoke study in your video titled “Replacement of Needle (Open door)” under file name “Act 44” does not appear to encompass all areas within the ISO 5 (b)(4) including but not limited to the interventions performed by the operator during needle replacement. 2. Regarding your personnel monitoring program, we have reviewed your provided evaluation and acknowledge your statement that, “the practice of breaking first air with the head and chest during open (b)(4) doors interventions has been remediated.” We also acknowledge that you have updated your SOP to “add personnel monitoring sample sites of the right shoulder and left shoulder for the machine assembly process.” However, in our review of your updated smoke study titled “Act 15” it appears that your operator’s head and goggles enter the ISO 5 space within the (b)(4) . [B175] See section 501 of the FDCA. [B154] [B152] [ See 21 CFR 210.1(b), 21 CFR 200.10(b).] In addition, regarding issues related to the conditions of section 503B of the FDCA, some of your corrective actions appear adequate: You state that you have “revised the affected labels to include the necessary statements and enhance the label review and approval process to ensure compliance with all regulatory standards in the future.” You did not address certain issues related to the conditions of section 503B of the FDCA. More specifically, your SOP for adverse event reporting does not adequately address adverse event reporting. For example, your procedures do not adequately define what constitutes an “unexpected” adverse event and your procedures do not provide that adverse events should be reported utilizing the Safety Reporting Portal (SRP) or Electronic Submission Gateway (ESG). [B171] [B150] [B155] [B253] E. [B126] [B2] [B20] [B153] [B1] [B166] [B17] [B0] [B16] [B4] All correspondence should refer to the Warning Letter Number above (# 703497) and include a subject line that clearly identifies the submission as a Response to Warning Letter. [B6] Sincerely, /S/ F. Gail Bormel, JD, RPh Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ___________________ 1 See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013). [B222] 3 For more information, see, FDA’s guidance, “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which can be found at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434188.pdf. 4 The specific products made by your firm are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B5] 5 Your compounded drug products are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115). Content current as of: 05/13/2025 Regulated Product(s)