

#### [87] genogenix-llc-718739-01202026 | issued 01/20/2026 | GenoGenix LLC | SUBJ: Compounding Pharmacy/Adulterated Drug Products
WARNING LETTER WL # 718739 January 20, 2026 Dear Mr. Miron: You registered your facility with the U.S. [B181] 1 on February 4, 2025. From July 14, 2025, to July 18, 2025, FDA investigators inspected your facility, GenoGenix LLC, located at 2840 NW 2nd Ave, Suites 204 & 205, Boca Raton, FL 33431. During the inspection, the investigators noted 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, which put patients at risk. FDA issued a Form FDA 483 to your facility on July 18, 2025, and issued an amended Form FDA 483 on July 31, 2025. We reviewed your August 29, 2025, September 30, 2025, October 31, 2025, and November 30, 2025, responses to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. FDA acknowledges that your firm has ceased drug production and distribution. FDA also acknowledges that on July 30, 2025, your firm initiated a voluntary recall of drug products intended or expected to be sterile, within expiry, due to lack of sterility assurance or microbial contamination. [B176] A. [B168] [B106] [B221] [B182] [B174] [B184] In addition, for a drug product compounded using bulk drug substances to qualify for exemptions under section 503B, the bulk drug substances that are used must appear on a list established by the Secretary identifying bulk drug substances for which there is a clinical need (“503B bulks list”), or the compounded drug must appear on the drug shortage list in effect under section 506E of the FDCA at the time of compounding, distribution, and dispensing (section 503B(a)(2)(A)(i) of the FDCA [21 U.S.C. § 353b(a)(2)(A)]). Furthermore, 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)]).] Moreover, 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 a report to FDA upon initially registering as an outsourcing facility, once in June of each year, and once in December of each year identifying the drug products compounded during the previous 6-month period (section 503B(b)(2) of the FDCA [21 U.S.C. §353b(b)(2)]), and 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 investigators noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigators noted: 1. Your facility compounded drug products using bulk drug substances that are not eligible for the use in compounding under section 503B, including 5-amino-1-methylquinolinium iodide (5-Amino-1MQ) and nicotinamide adenine dinucleotide (NAD+). Drug products compounded using 5-Amino-1MQ and NAD+ are not eligible for the exemptions provided by section 503B, because 5-Amino-1MQ and NAD+ do not appear on the 503B bulks list and are not used to compound a drug that appears on the drug shortage list. 3 2. Some of your facility’s drug products did not include the following required information on the label: a. The statement “this is a compounded drug.” Examples include Glutathione Magnesium, Reconstitution Solution, and Epithalon. b. The name, address, and phone number of the outsourcing facility. Examples include Glutathione Magnesium, Reconstitution Solution, and Epithalon. c. The established name of the drug. Examples include Rapamycin, Clear Mind 150, and LIPO (MIC) + B. d. The dosage form of the drug. Examples include LIPO (MIC) + B, Ascorbic Acid Vitamin C, Alpha Lipoic Acid, and Epithalon. e. Storage and handling instructions. Examples include Epithalon. f. The statement “Not for resale,” and, if the drug is dispensed or distributed other than pursuant to a prescription for an individual identified patient, the statement “Office Use Only.” Examples include Glutathione Magnesium, Reconstitution Solution, and Epithalon. 3. Some of your facility’s drug products did not include a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient on the label or container. Examples include Rapamycin, Clear Mind 150, Alpha Lipoic Acid, and Epithalon. 4. Some of your facility’s drug products did not include the following information on the container: a. Information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088. b. Directions for use, including, as appropriate, dosage and administration. Examples include Immune Defense Nasal Spray. 5. Your facility failed to submit a report to FDA upon initially registering as an outsourcing facility in February 2025 and in June 2025 identifying the drug products that you compounded during the previous 6-month period. 6. [B218] 4 Specifically, you do not have any documented procedures for reporting adverse events. [B283] 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. An operator blocked first air by placing gloved hands directly over open sterile containers. 2. An operator manually touched a product contact surface by reaching into a bag of stoppers with gloved hands, then hand stoppered vials of drug product. 3. Operators did not disinfect materials at each transition from areas of lower quality air to areas of higher quality air. 4. An operator placed components within the ISO (b)(4) hood that had the potential to block the movement of first air to critical in-process operations. 5. Personnel engaged in aseptic processing while exposing skin within the ISO (b)(4) aseptic processing area. 6. Personnel performing sterile operations never conducted media fills. [B249] 7. Your firm lacks adequate routine environmental monitoring. Specifically, your firm has never performed personnel or environmental monitoring during the production of drug products. 8. Your firm failed to conduct (b)(4) testing on (b)(4) used to sterilize drug products. Therefore, you do not have assurance that the (b)(4) throughout use. 9. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO (b)(4) area. [B148] 10. Your cleanroom is outfitted with HEPA filters directly adjacent to the return vents in the ceiling. This design may prevent the dilution of particle-laden air by HEPA filtered air. Therefore, your firm has no assurance of proper air circulation within your cleanroom where aseptic production occurs. 11. Your production areas are difficult to clean and contain porous surfaces. 12. Your facility is designed and operated in a way that may permit the influx of lesser quality air into a higher quality air area. Specifically, your cleanroom sliding glass doors have visible gaps that could compromise the integrity of the controlled environment. These openings create pathways for uncontrolled air movement and potential contamination transfer. 13. Your firm handled hazardous drug products without providing adequate containment, segregation, or cleaning of work surfaces and utensils to prevent cross-contamination. 14. Your firm produced drug products with materials that had not been verified to assure that they did not contribute endotoxin contamination that may be objectionable given the product’s intended use. FDA investigators 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. [B183] 2. 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)). 3. [B215] 4. Your firm failed to establish a system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)). 5. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). 6. Your firm failed to establish and follow written procedures prescribing a system for reprocessing batches that do not conform to standards or specifications and the steps to be taken to ensure that the reprocessed batches conform to all established standards, specifications, and characteristics (21 CFR 211.115(a)). 7. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)). 8. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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)). 9. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188). 10. Your firm failed to exercise strict control over labeling issued for use in drug product labeling operations (21 CFR 211.125(a)). 11. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). 12. Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a)). In addition, FDA investigators noted that your firm released and distributed several drug products in which the strength did not meet the label claim. For example, your firm released and distributed injectable methylcobalamin 5,000 mcg/mL, which was determined to have 65.3% the amount of methylcobalamin listed on the label, and injectable B Complex, which was determined to have 43.1% the amount of dexpanthenol listed on the label. Under section 501(c) of the FDCA [21 U.S.C. § 351(c)], a drug is deemed to be adulterated if it is unrecognized in an official compendium and its strength differs from, or its quality or purity falls below, that which it purports or is represented to possess. The strength of these compounded drug products differed from the strength represented on their labels, causing them to be adulterated under section 501(c) of the FDCA. Furthermore, FDA investigators noted your firm released and distributed a drug product that contained excessive bacterial endotoxins. More specifically, your firm initiated a complaint investigation after receiving a notification from a healthcare provider that three patients had developed adverse symptoms, including low blood pressure, uncontrollable shaking, shivers, and body aches shortly after or during the administration of a product compounded by your firm containing NAD+. According to the complaint report, these three patients received NAD+ Lot# GG121624-023 from the same vial and were directed to the emergency room. This product was compounded by your firm, but you did not perform any finished product testing prior to release. As part of your investigation, your firm sent the product in question to a contract laboratory for testing. An unopened vial from the same lot was found to contain excessive bacterial endotoxins with a reported value of 3,360 EU/mL. Under section 501(c) of the FDCA [21 U.S.C. § 351(c)], a drug is deemed to be adulterated if it is unrecognized in an official compendium and its strength differs from, or its quality or purity falls below, that which it purports or is represented to possess. Accordingly, your firm’s compounded product containing NAD+ is adulterated under section 501(c) of the FDCA. [B178] [B169] [B180] [B173] [B177] [B151] [B140] [B179] 5 Furthermore, you do not have any FDA-approved applications on file for the drug products that you repackage, such as Semaglutide, Tirzepatide, and Retatrutide. 6 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] 7 In addition, you do not have any FDA-approved applications on file for certain other products that you manufacture, such as Thymosin Beta-4. Products such as Thymosin Beta-4 are unapproved new drugs under section 505 of the FDCA [21 U.S.C. § 355(a)] and also biological products under section 351 of the Public Health Service Act (PHS Act) [42 U.S.C. § 262]. In order to lawfully market a drug that is also a biological product, a valid biologics license application (BLA) must be in effect under the PHS Act. Your biological products, such as Thymosin Beta-4, are not the subject of an approved BLA. The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(d) of the FDCA [21 U.S.C. § 331(d)]. 8 Misbranded Drug Products You compound drug products that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. You repackage drug products, such as Semaglutide, Tirzepatide, and Retatrutide, that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. You manufacture other products, such as Thymosin Beta-4, that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use this product safely for their intended uses. Accordingly, the labeling of these products fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA. 9 In addition, the strength of compounded products, specifically injectable Methylcobalamin 5,000 mcg/mL and injectable B12 Complex, differed from and fell below their labeled strength. Under section 502(a) of the FDCA [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Because the labeling of these products is false, they are misbranded under section 502(a) of the FDCA. The introduction or delivery for introduction into interstate commerce of the aforementioned products violates section 301(a) of the FDCA. [B167] Failure to Report Drugs As noted above, your facility failed to submit a report to FDA upon initial registration as an outsourcing facility in February 2025, and again in June 2025, identifying the drug products that you compounded during the previous 6-month period (section 503B(b)(2) of the FDCA). The failure to report drugs by an entity that is registered with FDA in accordance with section 503B(b) is a prohibited act under section 301(ccc)(3) of the FDCA [21 U.S.C. § 331(ccc)(3)]. D. Corrective Actions We have reviewed your facility’s responses to the Form FDA 483. We acknowledge your firm has ceased drug production and distribution. We also acknowledge that on July 30, 2025, your firm initiated a voluntary recall of drug products intended or expected to be sterile, within expiry, due to lack of sterility assurance or microbial contamination. Your corrective and preventive actions (CAPA) and supporting documentation, including the deviation investigations, specific procedures, implementation plans, or timelines to address the violations, are inadequate. These documents lack sufficient detail regarding the actions you are currently taking to address each specific violation within the observations, including but not limited to your failure to expand your investigations to related and deficient practices. Furthermore, you have not provided documentation of these changes, including but not limited to approved revisions, qualifications, validations, training, or other corrective action plans. [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, we are unable to fully evaluate the following corrective actions due to lack of adequate supporting documentation: 1. You state that you are “conducting a comprehensive review of all product formulations to verify that all raw materials, including bulk drug substances, are consistent with the requirements under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).” You also state that “any in-house drug products that contain bulk drug substances subject to evaluation will be segregated and quarantined pending determination of the appropriate disposition under regulatory requirements and internal procedures” and that “a formal procedure will also be developed to ensure that all drug products and bulk drug substances are verified against section 503B requirements on an ongoing basis.” However, you have not provided documentation regarding the disposition of drug products containing 5-amino-1MQ (5-amino-1-methylquinolinium iodide) and NAD+ (nicotinamide adenine dinucleotide) or evidence that you have ceased compounding these products. 2. While you acknowledge the importance of proper labeling and commit to developing procedures, your response lacks sufficient information. You have not provided a timeline for implementing corrective actions, stating only “TBD, depending on the timing of the (b)(4) .” Additionally, you have not provided documentation demonstrating that your current labeling practices have been corrected. Regarding issues related to the conditions of section 503B of the FDCA, some of your corrective actions appear deficient: 1. Your SOP for adverse event reporting does not adequately address adverse event reporting. For example: a. Your procedures do not adequately define what constitutes a “serious” adverse event; b. Your procedures do not define what constitutes an “unexpected” adverse event; and c. Your procedures do not adequately 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. 2. You have not submitted any report to FDA identifying the drug products that you compounded during the previous 6-month period. [B171] FDA strongly recommends that if you decide to resume production of drugs your management first undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. [B155] [B250] E. [B126] [B2] [B20] If you decide to resume operations to produce drugs, you should take prompt action to address any violations. [B1] Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations, or you may inform us that you do not intend to resume production of drugs. If you intend to resume production of drugs, please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. [B0] [B16] In addition to taking appropriate corrective actions, you should notify this office fifteen (15) working days prior to resuming production of any drugs. All correspondence should refer to the Warning Letter Number above (# 718739) and include a subject line that clearly identifies the submission as a Response to Warning Letter. [B6] Sincerely, /S/ Matthew J. Lash Acting 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 These substances are also not eligible for the policy applicable to certain bulk drug substances described in the final guidance titled, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Revision 1) . [B157] [B156] These conditions include that the drug product appears on “503B Category 1 – Bulk Drug Substances Under Evaluation”, which includes substances that may be eligible for inclusion on the 503B bulks list, was nominated with adequate support for FDA to evaluate it, and has not been identified by FDA as a substance that appears to present significant safety risks pending further evaluation. For additional information, see the guidance at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469122.pdf 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 These 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 The products repackaged 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. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their labeled uses. 7 Drugs that are repackaged are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FDCA. For additional information, you may wish to review FDA’s 2017 guidance document, “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.” More specifically, the guidance sets forth conditions under which FDA does not intend to take action against drug products repackaged by pharmacies and outsourcing facilities for certain violations of the FDCA. Such conditions include, but are not limited to, the drug product that is being repackaged is a prescription drug product that (1) is approved under section 505 of the FDCA; or (2) is an unapproved drug product that appears on the drug shortage list in effect under section 506E of the FDCA, and the repackaged drug product is distributed during any period in which it is listed on that drug shortage list or during the 30 days following such period. 8 Biological products subject to licensure under section 351 of the PHS Act are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FDCA. For additional information, you may wish to review FDA’s 2018 guidance document, “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.” More specifically, the guidance sets forth conditions under which FDA does not intend to take action for certain violations of the FDCA when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling. This guidance addresses the mixing, diluting, or repackaging of a licensed biological product, not a biological product licensed for further manufacturing use only or a bulk drug substance. The policies expressed in this guidance do not extend to any person or entity that mixes, dilutes, or repackages a biological product from any other starting material. 9 Your compounded, repackaged and manufactured 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: 03/03/2026 Regulated Product(s)

#### [88] thrive-health-and-wellness-llc-dba-thrive-health-solutions-714891-02092026 | issued 02/09/2026 | Thrive Health and Wellness, LLC dba Thrive Health Solutions | SUBJ: Compounding Pharmacy/Adulterated Drug Products
WARNING LETTER WL # 714891 February 9, 2026 Dear Mr. Hatch: From March 25, 2025, to April 3, 2025, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Thrive Health and Wellness, LLC dba Thrive Health Solutions, located at 88 Inverness Circle E Ste A-204, Englewood, CO 80112. During the inspection, 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 to your firm on April 3, 2025. FDA acknowledges receipt of your facility’s response, dated April 22, 2025. FDA further acknowledges that as of April 21, 2025, your firm ceased repackaging of sterile drug products not intended for immediate use. FDA also acknowledges that on May 21, 2025, your firm initiated a voluntary recall of all repackaged sterile drug products dispensed between January 2, 2025, to April 18, 2025, due to a lack of sterility assurance. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA). A. [B141] 1 B. [B252] For example, the investigator observed that: 1. Your personnel were observed conducting aseptic operations outside of a certified ISO 5 area. More specifically, your personnel filled sterile drug products into syringes on a benchtop table located in an unclassified room that shared the workspace with a blood sample centrifuge. These drug products were not intended for immediate administration to patients but were distributed for future administration outside your facility. 2. Your personnel performing sterile operations have never performed media fills. [B249] 3. Your aseptic processing and surrounding areas had difficult to clean equipment and surfaces. For example, your entire facility flooring was covered with carpet. 4. Your personnel engaged in aseptic processing while wearing non-sterile gloves and with exposed hair and skin. 5. Your firm failed to use a sporicidal agent as part of your disinfection program for the aseptic processing area and used non-sterile wipes to clean within the area where drug products were filled into syringes. [B151] [B140] Unapproved New Drug Products You do not have any FDA-approved applications on file for the drug products that you repackage, such as NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections 10mg/20mg/mL. 2 These products are unapproved new drugs 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. Marketing of these products, or other applicable products, without an approved application is prohibited under section 301(d) of the FDCA [21 U.S.C. § 331(d)]. 3 Misbranded Drug Products The drug products you repackage, such as NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections 10mg/20mg/mL, are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses. 4 Accordingly, these drug products are misbranded under section 502(f)(1) of the FDCA. The introduction or delivery for introduction of misbranded drugs into interstate commerce is prohibited under section 301(a) of the FDCA. It is also a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded. C. Corrective Actions We have reviewed your facility’s response to the Form FDA 483. We acknowledge that as of April 21, 2025, your firm ceased repackaging of sterile drug products not intended for immediate use. We also acknowledge that on May 21, 2025, your firm initiated a voluntary recall of all repackaged sterile drug products dispensed between January 2, 2025, to April 18, 2025, due to a lack of sterility assurance. D. [B126] [B2] [B20] If you decide to resume operations to produce sterile drug products not intended for immediate use, you should take prompt action to address any violations. [B1] Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations, or you may inform us that you do not intend to resume production of sterile drug products not intended for immediate use. If you intend to resume production of sterile drug products not intended for immediate use in the future, please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. [B0] [B16] In addition to taking appropriate corrective actions, you should notify this office fifteen (15) working days prior to resuming production of any drugs intended or expected to be sterile in the future. [B251] In your response, refer to the Warning Letter Number above (# 714891) and include a subject line that clearly identifies the submission as a Response to Warning Letter. Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ______________________ 1 We remind you that there are conditions other than those discussed in this letter that must be satisfied to qualify for the exemptions in section 503A of the FDCA. 2 The specific products repackaged 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. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their labeled uses. 3 Drugs that are repackaged are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FDCA. For additional information, you may wish to review FDA’s 2017 guidance document, “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.” More specifically, the guidance sets forth conditions under which FDA does not intend to take action against drug products repackaged by pharmacies and outsourcing facilities for certain violations of the FDCA. Such conditions include, but are not limited to, the drug product that is being repackaged is a prescription drug product that (1) is approved under section 505 of the FDCA; or (2) is an unapproved drug product that appears on the drug shortage list in effect under section 506E of the FDCA, and the repackaged drug product is distributed during any period in which it is listed on that drug shortage list or during the 30 days following such period. 4 The drug products you repackage, such as NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections 10mg/20mg/mL, 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: 04/21/2026 Regulated Product(s)

#### [89] 24hrdoc-inc-dba-24hrdoc-717984-02202026 | issued 02/20/2026 | 24HrDoc, Inc. dba 24HrDoc | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 24HrDoc: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.24hrdoc.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “24HrDoc” on the pictured label, suggesting 24HrDoc is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that 24HrDoc is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “Same ingredients as: Ozempic and Wegovy” “Same ingredients as: Mounjaro and Zepbound” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ____________________ 1 The semaglutide and tirzepatide products offered on your website 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [90] alan-health-technologies-inc-dba-alan-721814-02202026 | issued 02/20/2026 | Alan Health Technologies Inc. dba Alan | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Alan: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.alanmeds.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “Alan” on the pictured label, suggesting Alan is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Alan is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B11] [B208] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research _____________________ 1 The semaglutide and tirzepatide products offered on your website 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [91] aspen-aesthetics-dba-fifty-410-721481-02202026 | issued 02/20/2026 | Aspen Aesthetics dba Fifty 410 | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Fifty 410: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.fifty410.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “Fifty 410” on the pictured label, suggesting Fifty 410 is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Fifty 410 is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. Additionally, the following claim concerning compounded semaglutide and tirzepatide products appears on your website: “clinically proven ingredients” Compounded drug products are not FDA-approved. Your claim implies that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not. [B112] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. [B284] [B5] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [92] belle-health-llc-dba-belle-721795-02202026 | issued 02/20/2026 | Belle Health LLC dba Belle | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Belle: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.joinbelle.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “Belle” on the pictured label, suggesting Belle is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Belle is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B11] [B208] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. [B284] [B5] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [93] better-health-labs-inc-dba-measured-721454-02202026 | issued 02/20/2026 | Better Health Labs, Inc. dba Measured | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Measured: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://trymeasured.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “Measured” on the pictured label, suggesting Measured is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Measured is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “Measured offers compounded GLP-1 treatments made with the same active ingredients found in Wegovy®, Ozempic®, Zepbound®, and Mounjaro®.” “Same active ingredient in Ozempic and Wegovy” “Same active ingredient in Mounjaro and Zepbound” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ___________________ 1 The semaglutide and tirzepatide products offered on your website 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [94] bliv-wellness-llc-dba-bliv-721479-02202026 | issued 02/20/2026 | Bliv Wellness LLC dba Bliv | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Bliv: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.joinbliv.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “Bliv” on the pictured label, suggesting Bliv is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Bliv is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B11] [B208] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research _____________ 1 The semaglutide and tirzepatide products offered on your website 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [95] bluefitmd-721446-02202026 | issued 02/20/2026 | BluefitMD | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 BluefitMD: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.bluefitmd.com/, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “BluefitMD” on the pictured label, suggesting BluefitMD is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that BluefitMD is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “Compounded Semaglutide (the same active ingredient as Ozempic® and Wegovy®)” “Compounded Tirzepatide (the same active ingredient as Mounjaro® & Zepbound®)” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research _______________ 1 The semaglutide and tirzepatide products offered on your website 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [96] deluxe-iv-aesthetics-pllc-dba-deluxe-iv-and-aesthetics-721447-02202026 | issued 02/20/2026 | Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Deluxe IV and Aesthetics: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://deluxeivaesthetics.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “Deluxe IV and Aesthetics” on the pictured label, suggesting Deluxe IV and Aesthetics is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Deluxe IV and Aesthetics is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “Same active pharmaceutical ingredient in Ozempic® and Mounjaro®.” “Semaglutide is the active pharmaceutical ingredient in Ozempic®*, Rybelsus®*, and Wegovy®*” “Tirzepatide is the active pharmaceutical ingredient in Mounjaro®* and Zepbound®*.” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. [B285] [B5] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [97] dripgym-mobile-parent-llc-dba-amp-health-717992-02202026 | issued 02/20/2026 | Dripgym Mobile Parent, LLC dba Amp Health | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Amp Health: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://myamphealth.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products.1 As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “Amp Health” on the pictured label, suggesting Amp Health is the compounder of those drugs when in fact it is not.2 Accordingly, the representations on your website that Amp Health is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “The same active ingredient in Wegovy®*, Ozempic®*, and Saxenda®*” “Featuring the same active ingredient found in Mounjaro®* and Zepbound®*.” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research __________________ 1 The semaglutide and tirzepatide products offered on your website 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [98] fitrx-llc-dba-fitrx-717987-02202026 | issued 02/20/2026 | FitRX, LLC dba FitRx | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 FitRx: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.fitrxapp.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “FitRx” on the pictured label, suggesting FitRx is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that FitRx is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “semaglutide (active ingredient in Wegovy) or tirzepatide (active ingredient in Zepbound)” “we can ship semaglutide, the main active ingredient in Wegovy and Ozempic, or Tirzepatide, the main active ingredient in Zepbound and Mounjaro” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research _____________________ 1 The semaglutide and tirzepatide products offered on your website 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [99] genesis-health-international-inc-dba-genesis-721451-02202026 | issued 02/20/2026 | Genesis Health International Inc. dba Genesis | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Genesis: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.trygenesis.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “Genesis” on the pictured label, suggesting Genesis is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Genesis is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “Contains the same active ingredient as Ozempic® and Wegovy®” “Same active ingredient as Mounjaro®” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ________________________ 1 The semaglutide and tirzepatide products offered on your website 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [100] good-girl-llc-dba-goodgirlrx-721449-02202026 | issued 02/20/2026 | Good Girl LLC dba GoodGirlRX | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Ms. Chrisley: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://goodgirlrx.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “GoodGirl RX ” on the pictured label, suggesting GoodGirl RX is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that GoodGirl RX is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “FDA-approved meds.” “FDA-approved options” “Clinically proven GLP-1 results” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research _____________________ 1 The semaglutide and tirzepatide products offered on your website 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [101] ivim-services-llc-dba-ivim-721816-02202026 | issued 02/20/2026 | Ivim Services LLC dba Ivim | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Ivim: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.ivimhealth.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “Ivim” on the pictured label, suggesting Ivim is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Ivim is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B11] [B208] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ___________________ 1 The semaglutide and tirzepatide products offered on your website 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [102] join-josie-717986-02202026 | issued 02/20/2026 | Join Josie | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Join Josie: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://joinjosie.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “Join Josie” on the pictured label, suggesting Join Josie is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Join Josie is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “The same active ingredient found in the FDA-approved brand Wegovy®.” “The same active ingredient found in the FDA-approved brand Zepbound®.” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ____________________ 1 The semaglutide and tirzepatide products offered on your website 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [103] kare-solutions-llc-dba-zappy-717991-02202026 | issued 02/20/2026 | Kare Solutions, LLC dba Zappy | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Zappy: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://zappyhealth.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide, tirzepatide, and liraglutide drug products. 1 As described below, your website’s false or misleading claims concerning compounded semaglutide, tirzepatide, and liraglutide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B14] [B12] The compounded semaglutide, tirzepatide, and liraglutide products displayed on your website identify “Zappy” on the pictured label, suggesting Zappy is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Zappy is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. Additionally, the following claims concerning compounded semaglutide, tirzepatide, and liraglutide products appear on your website: “Semaglutide (Active Pharmaceutical Ingredient in Wegovy®)See Wegovy FDA Information” [sic] “Liraglutide (Active Pharmaceutical Ingredient in Saxenda®)See Saxenda FDA Information” [sic] “Tirzepatide (Active Pharmaceutical Ingredient in Zepbound®)See Zepbound FDA Information” [sic] “a proven medication” “Clinically studied and shown to deliver powerful results when combined with healthy habits.” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] For the reasons discussed above, your compounded semaglutide, tirzepatide, and liraglutide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ______________________ 1 The semaglutide, tirzepatide, and liraglutide products offered on your website 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [104] kin-meds-721450-02202026 | issued 02/20/2026 | Kin Meds | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Kin Meds: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://kinmeds.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “Kin Meds” on the pictured label, suggesting Kin Meds is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Kin Meds is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “Same Active Ingredient as common brands” “Hit weight management goals with the same weight loss ingredient as brand-name GLP-1 medications, at a fraction of the cost” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. [B284] [B5] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [105] lean-rx-inc-dba-skinnyrx-717989-02202026 | issued 02/20/2026 | Lean Rx, Inc. dba SkinnyRx | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 SkinnyRx: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://skinnyrx.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “SkinnyRx” on the pictured label, suggesting SkinnyRx is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that SkinnyRx is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “from the same family as GLP-1 treatments like Mounjaro® and Zepbound®” “Get access to the same active ingredient as name-brand GLP-1 medications” “It contains the same active ingredient as FDA-approved medications” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. [B285] [B5] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [106] levity-inc-dba-levity-717990-02202026 | issued 02/20/2026 | Levity Inc. dba Levity | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 Levity: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.joinlevity.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and liraglutide drug products. 1 As described below, your website’s false or misleading claims concerning compounded semaglutide and liraglutide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B14] [B12] The compounded semaglutide and liraglutide products displayed on your website identify “Levity” on the pictured label, suggesting Levity is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that Levity is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. Additionally, the following claims concerning compounded semaglutide and liraglutide products appear on your website: “The same ingredient as Ozempic® + Wegovy®” “The power of Saxenda®” Compounded drug products are not FDA-approved. [B70] [B15] [B11] [B69] For the reasons discussed above, your compounded semaglutide and liraglutide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research _____________________ 1 The semaglutide and liraglutide products offered on your website 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. 353(b)], FDCA §503B(a)(10)(A)(ii)[21 U.S.C. § 353b(a)(10)(A)(ii)]. [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)

#### [107] medvi-llc-dba-medvi-721455-02202026 | issued 02/20/2026 | MEDVi, LLC dba MEDVi | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER February 20, 2026 MEDVi: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://medvi.io, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. [B68] [B14] [B12] The compounded semaglutide and tirzepatide products displayed on your website identify “MEDVi” on the pictured label, suggesting MEDVi is the compounder of those drugs when in fact it is not. 2 Accordingly, the representations on your website that MEDVi is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)]. [B82] “Same active ingredient as Wegovy® and Ozempic®.” “Same active ingredient as Mounjaro® and Zepbound®.” Compounded drug products are not FDA-approved. [B70] [B15] [B11] The claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of violations. [B48] [B9] [B10] [B2] [B3] [B37] [B31] [B1] [B8] [B30] Such steps may include: [B33] [B35] [B0] [B38] [B4] [B13] [B34] [B7] [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ________________________ 1 The semaglutide and tirzepatide products offered on your website 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] [B39] [B32] FDCA §503(b) [21 § U.S.C. [B45] [B36] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B44] [B40] Content current as of: 03/03/2026 Regulated Product(s)