

#### [83] pq-pharmacy-llc-715795-10102025 | issued 10/10/2025 | PQ Pharmacy, LLC | SUBJ: Compounding Pharmacy/Adulterated Drug Products
WARNING LETTER WL # 715795 October 10, 2025 Dear Mr. Dimetry: You registered your facility with the U.S. [B181] 1 on October 29, 2020, and most recently on November 26, 2024. From March 25, 2025, to April 4, 2025, an FDA investigator inspected your facility, PQ Pharmacy, LLC, located at 15215 Technology Drive, Brooksville, FL 34604. During the inspection, the investigator 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 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 facility on April 4, 2025. FDA acknowledges receipt of your facility’s response, dated April 7, 2025. [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 collected evidence indicating that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigator collected evidence indicating that: 1. Some of your facility’s drug products, such as Prednisolone/Moxifloxacin HCl/Bromfenac PF Sterile Ophthalmic Solution and Prednisolone/Moxifloxacin HCl PF Sterile Ophthalmic Solution, did not include the established name of the drug. 2. Your facility did not 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, CFR (or any successor regulations).3 Specifically, your facility’s procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events do not include the following information in the definition of what constitutes a “serious” adverse event: “Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.” (21 CFR 310.305(b)). [B283] Specific violations are described below. C. [B252] For example, the investigator observed that: 1. An operator rested their arms on the work surface of the hood during aseptic production. This practice may introduce contamination into the ISO (b)(4) work area. 2. Operators conducted aseptic manipulations in an area where the movement of “first air” in the ISO (b)(4) area was disrupted by operator manipulations, including the failure to limit unnecessary movement and make mindful, slow, deliberate movements within the ISO (b)(4) laminar flow hoods and within the ISO (b)(4) cleanroom suite. 3. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO (b)(4) area. [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. Your firm failed to establish adequate 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)). 2. Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). 3. [B216] 4. [B215] [B178] [B169] [B180] [B173] [B177] [B151] [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 response to the Form FDA 483. Some of your corrective actions appear adequate; however, we are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation: 1. You did not provide scientific justification for the selection of (b)(4) intensity to conduct visual inspection for all sterile products. 2. You did not provide training records and personnel qualification records for procedure S203005.3 Qualification of Personnel for Particulate and Defect Inspection Activities. Some of your corrective actions appear deficient: 1. Regarding your failure to conduct hold time studies, we note that you have provided methods, such as media fill runs, to mitigate certain risks; however, these measures alone are insufficient. A hold time study remains necessary to evaluate container closures of the bulk holding material, testing of the bulk material being held prior to further processing, potential risk associated with sterility, contamination, product degradation, adsorption, or absorption. Furthermore, you failed to establish adequate written procedures for production and process controls, including but not limited to the following: a. Hold time studies to justify your (b)(4) -day holding of bulk product. b. Hold time studies to include the impact of an additional (b)(4) step, particularly in cases where such steps are used to extend the bulk hold period beyond the initial (b)(4) -days. c. Process validation, to include your (b)(4) step following detection of particulates or to provide a scientific study justifying this step. Moreover, you failed to define when an investigation is warranted in the event a product requires (b)(4) . For example, your standard operating procedures do not mandate a root cause investigation in cases of (b)(4) failure or particulate observation beyond initiating a deviation. Additionally, your classification of deviations, such as “Critical Deviation,” does not include the definition for (b)(4) resulting from (b)(4) failures (b)(4) . 2. Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. More specifically, you failed to expand your investigations into other products using the same lots of affected material (i.e. bulk bags, syringes, or (b)(4) ). Although you state that a review was conducted, the deviation report does not include a list of the specific lots that were assessed. Relying solely on trending data is not sufficient to justify the scope of an investigation. a. Regarding the (b)(4) of the bulk solution bag, your response fails to clarify whether your (b)(4) process has been validated for repeat (b)(4) procedures. While your firm has identified the likely root cause of deviation DEV2024072 as intrinsic to the interior of the bulk bag, your response does not demonstrate that you have conducted adequate analysis beyond verifying expiration dates. Furthermore, there is no evidence that you examined other products manufactured using the same lot of bulk bags that produced the contaminated material, nor did you conduct additional review of retained samples that could provide valuable insight into the scope of this issue. Moreover, you did not investigate the integrity of the bags’ material nor conduct further investigation including communicating with the manufacturer. In addition, particulate testing appears to have been conducted only after the repeated (b)(4) , which raises concerns that the nature and extent of the contamination were not being appropriately characterized. b. Regarding your failure to follow-up on the root cause determination of DEV2024075, numerous critical deficiencies remain unaddressed and require comprehensive corrective and preventative actions. Your investigation does not include an adequate root cause analysis as you failed to review other products using the same lot of syringes, conduct any review of retained samples, or provide identification and characterization of the particulates to determine how they differed from the 19 rejects identified during 100% visual inspection. Additionally, your response does not address whether you investigated the integrity of the syringes themselves or notified the syringe manufacturer or distributor of this potential component-related issue. c. You failed to follow-up your root cause determination of DEV2023007 related to the sterile (b)(4) . Additionally, you did not conduct process validation for the change involving the flushing and discarding of the first (b)(4) or (b)(4) mL of product (depending on the product). You also conducted no further investigation into the (b)(4) issue, including communication with the manufacturer. d. Your conclusion that post-bulk fill contamination was addressed through (b)(4) does not identify the original source of the contamination. Additionally, you provided no assessment or strategy to prevent further (b)(4) contamination from reoccurring. e. You did not provide a risk analysis of the products produced during the observed poor aseptic practices, nor was this analysis extended to other drug products produced on the same days. Disposition was also not provided for the following products, including whether they were released or distributed: Product Lot number Production date Prednisolone Sodium Phosphate/Moxifloxacin HCl/Bromfenac PF PMB032025NFG 3/26/2025 Prednisolone Sodium Phosphate/Moxifloxacin HCl/Bromfenac PF PMB032025NFG1 (5.6mL) 3/28/2025 Prednisolone Sodium Phosphate/Moxifloxacin HCl/Bromfenac PF PMB032025EO1 (8.6mL) 3/28/2025 Semaglutide 5mg vials SEM032525JP 3/28/2025 3. Your smoke studies remain inadequate to demonstrate proper unidirectional airflow within the ISO (b)(4) area. While we acknowledge that your smoke studies now include dynamic studies mimicking the operations of capping and crimping, these studies reveal airflow deficiencies that could compromise aseptic operations. Specifically, video 4 (b)(4) Static shows from time 0:59 to 1:37 the smoke arching past multiple rows of vials as it exits the front of the hood, indicating disrupted laminar flow that could transport contaminants across the work surface. Additionally, multiple objects such as the sampling plates and the sampler, are placed in front of the ventilation at the back of the hood, creating physical barriers that disrupt the intended unidirectional airflow pattern. [B175] See section 501 of the FDCA. [B154] [B152] [See 21 CFR 210.1(b), 21 CFR 200.10(b).] [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 (# 715795) 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: 12/02/2025 Regulated Product(s)

#### [84] apothecary-pharma-llc-717972-12012025 | issued 12/01/2025 | Apothecary Pharma, LLC | SUBJ: Compounding Pharmacy/Adulterated Drug Products
WARNING LETTER WL # 717972 December 1, 2025 Dear Ms. Rana: You registered your facility with the U.S. [B181] 1 on September 7, 2024, and most recently on January 11, 2025. From May 12, 2025, to May 15, 2025, FDA investigators inspected your facility, Apothecary Pharma, LLC located at 1913 Evans Road, Cary, NC 27513. 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 intended or expected to be sterile, which put patients at risk. FDA issued a Form FDA 483 to your facility on May 15, 2025. FDA acknowledges receipt of your facility’s response, dated June 9, 2025, and related attachments received July 17, 2025. FDA acknowledges that your firm ceased sterile drug production as of May 12, 2025, and notified FDA of an intent to resume sterile drug production on August 1, 2025. [B176] A. [B168] [B106] [B221] [B182] [B174] [B184] 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)]). In addition, 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 noted: 1. Some of your facility’s drug products, such as Tirzepatide Injection 10 mg/mL and Semaglutide Injection 2.5 mg/mL, did not include the following information on the label: a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient. Additionally, some of your facility’s drug products did not include the following information on the container: information to facilitate adverse event reporting and directions for use, including, as appropriate, dosage and administration. 2. [B218] 3 Specifically, your facility’s procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events do not include a definition of what constitutes a “serious” and “unexpected” adverse event (21 CFR 310.305(b)). [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: 1. An operator blocked first air by placing gloved hands directly over open sterile containers. 2. An operator placed components within the ISO 5 work area that had the potential to block the movement of first air to critical in-process operations. Specifically, an operator positioned a second row of exposed vials behind a first row in the ISO 5 (b)(4) laminar flow hood, obstructing first air to critical surfaces. 3. An operator rested their arms on the work surface of the hood during aseptic production. This practice may introduce contamination into the ISO 5 work area. 4. An operator placed their gloved hands outside the ISO 5 work area to retrieve supplies without sanitizing their gloved hands before re-entry into the ISO 5 hood. 5. Personnel engaged in aseptic processing while exposing skin within the ISO 5 aseptic processing area. 6. [B219] [B148] 7. Personnel moved quickly in a critical area such that unidirectional airflow is likely to be disrupted. 8. Production areas or equipment have difficult to clean and visibly rusty equipment or surfaces. 9. Lack of disinfection of equipment and supplies at each transition from areas of lower quality air to areas of higher quality air. 10. Failing to disinfect or change gloves frequently enough given the nature of the operations to prevent contamination. More specifically, personnel were observed touching equipment or other surfaces located outside of the ISO 5 area with gloved hands and then proceeding with aseptic processing without changing or sanitizing gloves. 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. Your firm failed to establish written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)). 2. [B183] 3. Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)). 4. Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)). 5. 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)). 6. 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). [B178] [B169] [B180] [B173] [B177] [B151] [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 response to the Form FDA 483. FDA acknowledges that your firm ceased sterile drug production as of May 12, 2025, and notified FDA of an intent to resume sterile drug production on August 1, 2025. Some of your corrective actions appear adequate; however, we are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation: 1. We acknowledge your corrective actions addressing operating with draft procedures and improper visual inspection techniques, including finalization of SOPs for Quality Unit responsibilities, Corrective and Preventive Action (CAPA), batch record review, out-of-specification (OOS) results, and retraining on the visual inspection SOP. However, your response remains inadequate because draft SOPs for Change Control, Deviations, and Risk Assessment were not addressed, and you did not assure that draft versions will not be used. In addition, you did not provide competency verification or supervisory oversight of retrained inspectors, nor a retrospective review of batches inspected under improper techniques. 2. We acknowledge your actions regarding inadequate skin coverage posing a contamination risk to sterile drug products, including internal training to SOP 0003.00 with emphasis on mirror self-inspection. However, the adequacy of your response cannot be fully evaluated because you did not provide supporting documentation, competency verification, post-retraining assessments, or updates to SOP 0003.00/procedures to enforce mirror checks. Further, although production was halted until August 1, 2025, you did not submit evidence of interim controls or monitoring results demonstrating proper gowning to assure ongoing compliance thereafter. Some of your corrective actions appear deficient: 1. Regarding your firm’s failure to establish written responsibilities and procedures applicable to the quality control unit, we acknowledge your voluntary halt of production on May 12, 2025, and your commitment to implementing corrective actions by August 1, 2025. However, your response is inadequate for the following reasons: a. Your response lacks a retrospective review plan for released batches (b)(4) , (b)(4) and fails to include a root cause analysis for why incomplete records were initially released. You have not provided training records demonstrating staff understanding of the new SOP 1012.00 procedures or evidence that the enhanced batch record review process addresses all identified deficiencies. b. While you engaged (b)(4) Air for re-certification, you have not acknowledged (b)(4) ' license revocation since 2014 or provided a plan to validate prior certifications. Your response lacks vendor qualification procedures (e.g., revising SOP 1009.00) and certification review processes. There is no assessment of previously released products manufactured in potentially uncertified environments, which compromises patient safety. 2. We acknowledge your engagement of (b)(4) Air and your retraining efforts related to aseptic operations. However, your response is inadequate because: a. You did not provide detailed protocols to ensure dynamic smoke studies simulate true production with maximum equipment and personnel, nor did you define acceptance criteria or Quality Unit oversight for vendor-conducted studies. b. You failed to conduct a risk assessment for the (b)(4) Tirzepatide 10 mg/mL batches released without validated airflow studies, or to provide an impact evaluation or justification for their release. c. Critical validation gaps remain, including no commitment to perform smoke studies in the ISO 7 cleanroom and no methodologies to improve smoke volume, background contrast, or dynamic simulation. d. Aseptic technique retraining did not address specific behaviors that compromise first air (e.g., blocking critical surfaces, resting forearms on ISO 5 surfaces, leaning into hoods and exposing skin). e. You proposed no workspace/equipment modifications to ensure all vials receive unidirectional airflow, and you did not evaluate equipment configurations to mitigate this risk. 3. We acknowledge your retraining to SOP 0003.00 with emphasis on mirror self inspection. However, your response is inadequate because: a. SOP 0003.00 was not updated to reflect the correct gowning sequence or to establish procedures that enforce mirror checks and supervisory oversight. b. You did not provide supporting documentation or competency verification demonstrating proper gowning technique; no post-retraining assessments were submitted. c. You did not address observed deficiencies (e.g., use of safety glasses instead of cleanroom goggles, crossing the demarcation line on the “dirty” side, and masks worn upside down). d. Procedural gaps remain regarding shoe covers over clogs when entering ISO-classified areas. e. Although operations resumed on August 1, 2025, you did not provide evidence of interim controls or monitoring results demonstrating continued compliance after August 1, 2025, or plans to assure ongoing compliance thereafter. 4. We acknowledge your commitment to address the condition of the ISO 5 laminar airflow hood (LAFH) by August 1, 2025. However, your response is inadequate because: a. You did not provide essential supporting documentation such as photographic evidence, maintenance records, or updated SOPs, while providing only vague commitments to repair rust damage without specifying repair methods. No interim controls or monitoring were described to mitigate contamination risk while the compromised LAFH remained in service, including upon resumption of operations on August 1, 2025. b. The root cause analysis attributing rust to (b)(4) lacked supporting evidence and did not include revised cleaning protocols, verification, or preventive measures; dents and peeling paint were inappropriately characterized as “cosmetic.” c. Reliance on media fills, sterility tests, or prior certifications does not address equipment condition defects that can harbor contamination or disrupt airflow pattern. d. You failed to provide supporting documentation including photographs, maintenance records, engineering assessments, updated SOPs, or qualification protocols, to demonstrate the implementation and effectiveness of your proposed changes. You did not provide an impact assessment for distributed batches compounded on this LAFH or establish a robust preventive maintenance program to prevent recurrence. 5. We acknowledge retraining to SOP 0004 (Ideal Conduct in Cleanroom) and SOP 2001.00 (Cleanroom Material Transfer). However, your response is inadequate because: a. You did not revise your SOPs to establish specific disinfection protocols with clear responsibilities and acceptance criteria. b. You did not provide a comprehensive CAPA plan that includes thorough root cause analysis, implementation evidence, or monitoring strategies to verify effectiveness of corrective actions. c. You failed to provide training documentation and competency assessments demonstrating that personnel can correctly perform material transfer procedures and maintain proper glove hygiene practices. The proposed sanitize-able metal tool for trash handling lacks specificity and does not mitigate immediate contamination risks during aseptic operation. d. You did not submit an ongoing compliance plan (e.g., routine observation, audit checklists, personnel monitoring targets) or interim controls upon resumption of operations on August 1, 2025. 6. We acknowledge your retraining to SOP 2004 (Visual Inspection). However, your response is inadequate because: a. You failed to revise batch records and procedures to include proper defect classification (critical/major/minor), Acceptable Quality Levels (AQL) methodology, and acceptance criteria. Additionally, you did not provide an updated Form F-2004.00-01, and AQL documentation continues to be omitted from your quality control processes. You did not submit documentation demonstrating retraining effectiveness (e.g., training curriculum, attendance, competency assessments, completion dates) or supervisory oversight of inspectors. b. You failed to provide impact assessment or retrospective review of distributed lots AP-202505 through AP-202513 to determine whether visual inspection deficiencies affected product quality. c. You failed to provide finalized SOP revisions or evidence of implementation; Annexure-1 lacked sufficient detail to verify changes. d. The referenced CAPA lacked specific corrective actions, milestones, responsible owners, and effectiveness checks. Given the nature and significance of the violations identified, FDA remains concerned that your firm has not yet demonstrated that adequate correction has been properly implemented to sustain sterile drug product manufacturing in a manner fully consistent with CGMP. [B150] [B155] [B250] [B175] See section 501 of the FDCA. [B154] [B152] [See 21 CFR 210.1(b), 21 CFR 200.10(b).] [B171] E. [B126] [B2] [B20] [B153] [B1] [B166] [B17] [B0] [B16] [B4] All correspondence should refer to the Warning Letter Number above (# 717972) 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: 03/17/2026 Regulated Product(s)

#### [85] darmerica-llc-716152-12082025 | issued 12/08/2025 | Darmerica, LLC | SUBJ: CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
WARNING LETTER Darmerica, LLC MARCS-CMS 716152 — December 08, 2025 More Warning Letters Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-26-24 Product: Drugs Recipient: Recipient Name Mr. Kyle Hamza Recipient Title Vice President Darmerica, LLC 4380 Oakes Road, Suite 800 Davie , FL 33314 United States Khamza@darmerica.com kyle@darmerica.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-24 December 8, 2025 Dear Mr. Hamza: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Darmerica, LLC, FEI 3012389174, at 4380 Oakes Road, Suite 800, Davie, from March 3 through 19, 2025. This warning letter summarizes significant violations, including deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). Your introduction or delivery for introduction into interstate commerce of adulterated drugs is a violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a). In addition, Darmerica has distributed drugs that are misbranded within the meaning of section 502(a) of the FD&C Act, 21 U.S.C. 352(a), due to false or misleading labeling, and section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), due to labeling without adequate directions for use. Darmerica also distributed drugs that are misbranded within the meaning of section 502(o) because they were not properly listed in accordance with section 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207. Your receipt in interstate commerce of misbranded drugs, and your introduction or delivery for introduction into interstate commerce of misbranded drugs, violate sections 301(c) and 301(a) of the FD&C Act, 21 U.S.C. 331(c) and 331(a), respectively. In addition, failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). These violations are described in more detail below. We reviewed your April 7, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigators observed specific deviations including, but not limited to, the following. A. Adulterated Drugs Failure of your quality unit to exercise its responsibility to ensure that APIs manufactured at your facility are in compliance with CGMP. FDA investigators observed that your firm lacked adequate quality unit (QU) oversight for the receipt of materials, repackaging, relabeling, and related controls for your APIs, which causes the drugs you distribute to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act. The introduction of such drugs into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Examples of failures of your QU are listed below. 1. Failure to Ensure that Your System for Evaluating Suppliers was Adequate FDA’s inspection revealed that your firm received API from (b)(4) , FEI (b)(4) . Darmerica also served as the firm’s U.S. agent starting in (b)(4) . Darmerica remained listed as the U.S. agent for (b)(4) until (b)(4) de-registered its establishment in FDA’s registration system on (b)(4) . The first documented shipment from (b)(4) to Darmerica was in (b)(4) , and the last shipment to Darmerica was in (b)(4) , (b)(4) prior to the FDA inspection at (b)(4) . You initially approved (b)(4) as a supplier in (b)(4) and requalified the firm in (b)(4) . As an example of a failure of your QU, as part of this qualification process, (b)(4) completed a vendor survey that asked whether it had had any regulatory inspections. In (b)(4) , (b)(4) answered in the affirmative, stating that an inspection by FDA resulted in a “satisfactory” outcome even though the U.S. FDA had not inspected the firm. However, the vendor survey completed by (b)(4) in (b)(4) stated that it had not had any regulatory inspections. There is no indication that your firm investigated this discrepancy prior to requalifying (b)(4) . Additionally, your quality agreements with (b)(4) included the provision of ongoing stability data generated per a stability protocol and annual stability data for appropriate packaging configuration. However, during an FDA inspection of (b)(4) in (b)(4) , FDA investigators observed that there were no stability chambers nor stability and reserve samples available. In addition, the facility did not provide any stability data for at least one lot of each API manufactured in (b)(4) to our investigator. This encompasses the timeframe in which you received drugs from (b)(4) under the terms of the quality agreements that, consistent with your procedures, required adequate stability data as part of supplier qualification. If (b)(4) was unable to and/or did not provide stability data to your firm as required under your (b)(4) quality agreement, qualifying the firm as a supplier again in (b)(4) would indicate another failure of your system for evaluating suppliers. Your response to the Form FDA 483 is inadequate. You indicate that your firm’s failure to verify (b)(4) responses to a vendor survey “is not a failure for Darmerica to qualify all other manufacturers” as per your SOP. However, your firm qualified a supplier that gave inconsistent responses about its inspectional history and was not equipped to provide stability data for its products as required by your quality agreement. Your firm then imported and distributed drugs from that supplier despite its apparent failure to comply with the terms of your quality agreement. As noted below, based on our inspection of records at your facility and a review of FDA import data, FDA is also aware of non-compliance among other firms that have previously supplied APIs to your firm. 2. Failure to Adequately Investigate Quality-Related Complaints and Recalls Our inspection also revealed that your firm did not adequately investigate customer complaints. Specifically, your QU failed to extend product quality complaint investigations to other lots of APIs potentially associated with the root cause, failure, or deviation. For example, you were made aware by (b)(4) on May 9, 2023, and (b)(4) on July 10, 2023, that (b)(4) lot (b)(4) manufactured by (b)(4) , FEI (b)(4) , contained black chunks that did not appear consistent with previous lots of the drug. You distributed API from this lot (b)(4) times to (b)(4) different customers. After receiving the complaint, your firm returned the remaining amount of lot (b)(4) in Darmerica’s inventory to the API manufacturer but did not contact your additional (b)(4) customers or investigate further whether they had also received complaints about any potential contamination. In your response, you state that the Darmerica’s investigation found that the particles were part of the (b)(4) shedding during the manufacturing process and that the supplier classified them as “technically unavoidable particles” that did not affect product quality. You conveyed to the two customers that complained about the product that your supplier suggested that the particles be removed manually. Notably, however, your QU decided to return your remaining impacted inventory of lot (b)(4) to the manufacturer without further investigation. Your response is inadequate. Though your firm conveyed the supplier’s confirmation of the issue to the two customers who initially submitted complaints, you failed to contact your other customers to determine whether they had experienced a similar problem. Your response states that “[a]ll other customers who bought the same product did not have any issue with the product,” but this cannot be confirmed if your firm did not contact those customers to investigate the matter. Further, your supplier’s response is indicative of a fundamental lack of understanding of CGMP, as the proposal for customers to manually remove the (b)(4) particles does not satisfy the requirement for drugs to meet the quality and purity characteristics they purport to possess. FDA is concerned that Darmerica accepted this supplier’s response as compliant with CGMP. There is no indication that your firm followed up on this supplier’s response any further or considered whether it was appropriate to continue purchasing API from a firm that displayed such a fundamental lack of understanding of CGMP. Notably, you distributed to clients a different lot of (b)(4) , lot (b)(4) , manufactured by the same supplier, that you received prior to the second complaint on July 10, 2023 and before the manufacturer could have corrected the issues with the equipment used in the manufacture of (b)(4) API. In addition, your recall procedure lacked clarity on how to handle supplier recalls. For example, your firm quarantined all (b)(4) products immediately after receiving a notice on (b)(4) , of the firm’s voluntary recall of drugs from the U.S. market after FDA documented violations at this facility. All remaining (b)(4) material in stock at your firm was returned to (b)(4) . However, there is no documented evidence that you informed your downstream customers of (b)(4) voluntary recall of drugs from the U.S. market or of the firm’s violative inspection. Your quality manager said clients were contacted via telephone, but there is no documented evidence that you contacted the numerous customers that received drugs manufactured by (b)(4) . None of the APIs distributed to customers were returned to Darmerica. We acknowledge that your response included an updated recall procedure that requires future client contact to be documented. 3. Failure to Ensure Adequate Pre-Release Testing of APIs Your firm lacked adequate QU oversight for the relabeling and repackaging of your API. Specifically, your firm failed to perform adequate testing and approve the results for your APIs prior to their release and distribution. For example, your firm released APIs for distribution prior to your QU completing its review. According to your records, your firm received and distributed a (b)(4) API, (b)(4) , lot (b)(4) on (b)(4) . Though a sample was sent to your third-party testing laboratory for analysis, the (b)(4) distribution of the (b)(4) API occurred prior to your firm’s own QU release of the (b)(4) API on (b)(4) and before the certificate of analysis (COA) was reviewed and authorized by your third-party lab on (b)(4) . In your response, you state that due to patients’ need of the medication, the lot was released and distributed before the third-party lab tests were completed. This response is inadequate because without adequate testing, you cannot demonstrate that incoming materials conform to appropriate specifications prior to use in the manufacture of your drugs. As a manufacturer, you have a responsibility to sample, test, and examine incoming materials before release for use in production to assure adequate quality. This violation is of heightened importance given FDA’s documented compliance concerns related to API manufacturers in your supply chain. In response to this letter, provide: A detailed list containing API name, manufacturer name, manufacturer lot number, date of entry, import entry number, port of entry, order number, quantity, grade, usage, date of receipt, and information regarding the first date distributed, such as customer name and address, for all drugs received by your firm within three years from the date of this letter. If an import entry number is not available, that should be noted and provide the shipping records that you have (e.g. invoice, bill of lading, waybill, etc.). The following information, based on a comprehensive review of your material system: o Whether you have notified your customers that they received adulterated drugs from your firm. If you have not notified any customer who received adulterated drugs from Darmerica, notify them, and provide a copy of that notification in your response. The notification should include lot identification, recommended actions, and customer acknowledgement. o Evaluating all manufacturers of materials to determine if they are reliable and appropriately qualified. o An assessment of all materials to determine whether they are consistently of acceptable quality. Supplier qualification procedures implemented for new API manufacturers and supply chain verification measures taken by your firm, including the selection, qualification, and disqualification provisions. A detailed list of the manufacturers that have been evaluated for approval and/or qualification within the past three years from the date of this letter. This list should include, but not be limited to manufacturer name, address, FDA Establishment Identifier (FEI), point of contact and email address, current status (e.g., acceptable, unacceptable, disqualified, or hold), date approved, and whether a quality agreement is in place with the manufacturer. Any manufacturers that had their status changed from acceptable to unacceptable or disqualified should note the date this occurred and reason why. Based on a thorough review, provide a summary of your systemic corrective action and preventive action (CAPA) to remediate the vendor qualification program and prevent use of unsuitable material suppliers. A full reconciliation of any drugs from (b)(4) , as well as for all firms or drugs currently on FDA import alerts, to determine if you have any remaining drugs from those firms in your possession. Up to date information regarding import alerts can be found at the following FDA website: https://www.accessdata.fda.gov/cms_ia/ialist.html. A list of investigations initiated within the past three years for deviations, discrepancies, complaints, out-of-specification (OOS) results, and failures. A comprehensive assessment of your overall complaint system, including a comprehensive list of all complaints where you returned drugs to the manufacturer, as well as information on whether you contacted your customers to investigate each complaint and the date of that contact, if applicable. If you have not contacted your customers to investigate each complaint, contact them, and provide a copy of that contact in your response. Provide a detailed action plan to remediate your complaint system. Your action plan should include, but not be limited to, o Significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, QU oversight, and written procedures. o Address how your firm will ensure all phases of investigations are appropriately conducted. A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to: o A determination of whether procedures used by your firm are robust and appropriate. o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices. o A complete and final review of each lot and its related information before the QU disposition decision. o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products. CGMP Consultant Recommended Based upon the nature of the deviations identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations to assist your firm in meeting CGMP requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA. Your use of a consultant does not relieve your firm’s obligations to comply with CGMP. [B245] B. Misbranded Drugs As discussed below, your firm received and distributed misbranded drugs in interstate commerce, which are prohibited acts under sections 301(c) and 301(a), respectively. 1. Distribution of drugs lacking adequate directions for use You received retatrutide from your supplier, (b)(4) , FEI (b)(4) . Retatrutide is a GLP-1 API that is not identified as an active ingredient in any drug approved by FDA. You distributed this API to pharmacies seeking to compound human drugs under section 503A of the FD&C Act even though retatrutide is not eligible for use in compounding under section 503A. Additional APIs that you distribute or distributed to compounders seeking to operate under section 503A of the FD&C Act that are ineligible for use in human drug compounding under sections 503A include: dapoxetine hydrochloride, 2-methoxyestradiol (2ME2), tesofensine, FGL acetate aka [GLP-1]-FGL peptide acetate, thymogen, buserelin acetate, elamipretide (SS-31) acetate, larazotide acetate, and cagrilintide acetate. The labeling of these drugs fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. Such APIs are not exempt from section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), under FDA regulations (see 21 C.F.R. Part 201), and, as noted, they are intended for use in a compounded drug that would be ineligible for the exemptions provided by section 503A of the FD&C Act, 21 U.S.C. 353a. The introduction or delivery for introduction into interstate commerce of these drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a). We have reviewed your May 1, 2025, email submitted in response to our April 2, 2025, teleconference, in which you discuss your distribution of the APIs retatrutide base and cagrilintide acetate. We acknowledge your statement, “Darmerica has ceased importing/distributing Retatrutide and delisted the NDC registration from FDA’s CDER website. As discussed during the April 02, 2025, meeting with FDA, Darmerica stopped the importation and distribution of Cagrilintide and is in the process of delisting the NDC registration from the FDA’s CDER website.” Your corrective actions related to retatrutide base and cagrilintide acetate appear adequate. 2. Receipt of drugs whose labeling is false or misleading Under section 502(a) of the FD&C Act, a drug is misbranded if its labeling is false or misleading in any particular. Your firm received multiple shipments of API that you knew to be mislabeled. Since March 2022, GLP-1 APIs were shipped to your firm as “custom peptide,” omitting the drug name. Because of this material omission, the labeling of the drug is false or misleading, causing the drug to be misbranded under section 502(a). We note that you acknowledged that this occurred, indicating it was to prevent theft of high demand products and to address the country’s export requirements for specific peptides. 3. Receipt of drugs from establishments not duly registered with FDA and failure to provide listing information to FDA Section 510 of the FD&C Act, 21 U.S.C. 360, and 21 CFR Part 207 set forth the requirements for establishment registration and drug listing. Under section 502(o), a drug is misbranded if, among other things, it was manufactured in an establishment not duly registered under section 510, or if it was not included in a list required by section 510(j). Under section 301(a), it is a prohibited act to introduce or deliver for introduction into interstate commerce any drug that is misbranded, and under section 301(c), it is a prohibited act to receive in interstate commerce a drug that is misbranded. In addition, failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). You received and distributed drugs from facilities that were not duly registered with FDA. For example, you provided an incorrect address for (b)(4) , during the March 2025 inspection; that same address was listed in the firm’s establishment registration. An internet search of this firm’s address indicated that it was a residential building and not an API manufacturing facility. After placing the facility on import alert, FDA physically visited the address and confirmed that it is an empty apartment in a residential building. According to the firm’s registered point of contact, the firm had gone out of business the year before; the point of contact did not know who manufactured or distributed GLP-1 APIs that you received and distributed to your customers for use in GLP-1 drug products administered to patients in the United States. This supplier was not duly registered with FDA under section 510 of the FD&C Act, causing its drugs to be misbranded within the meaning of section 502(o). In addition, you distributed drugs for which you did not provide listing information under section 510(j). Specifically, under section 510(j)(1)(C) of the FD&C Act, 21 U.S.C 360(j)(1)(C), and 21 CFR 207.49(a)(4), a registrant must include in drug listings the name and quantity of each API in their listed drugs. In at least 23 of your drug listings, the proprietary name, non-proprietary name, and/or product labeling do not match the active ingredient provided in the Structured Product Labeling (SPL). For example, in your listing for the drug “Hexarelin Acetate” (NDC 71052-621), you list the active ingredient as peptide B27PD in the SPL. Similarly, in the listing for the drug API “Elamipretide (SS-31) Acetate” (NDC 71052-907), you list the active ingredient as peptide B27PD in the SPL. Therefore, “Hexarelin Acetate” and “Elamipretide Acetate” are not listed in accordance with section 510(j)(1)(C) of the FD&C Act, 21 U.S.C 360(j)(1)(C), and 21 CFR 207.49(a)(4), rendering them misbranded under section 502(o) of the FD&C Act, 21 U.S.C 352(o). The introduction of misbranded drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). It is your responsibility to ensure that all products manufactured at your establishment and those that you repackage/relabel comply with all establishment registration and drug listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, 21 CFR Part 207, and all other applicable FDA regulations. Registration and listing information and instructions on how to properly register an establishment or submit drug listings can be found in the FDA Electronic Drug Registration and Listing Instructions at https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions. Other Concerns Drug Suppliers in Your Supply Chain with a History of Non-Compliance We note that a review of records collected from an inspection at your facility and a review of FDA import data demonstrated that FDA has, in the past, put more than (b)(4) of the manufacturers who supply your APIs on import alert because the drugs they manufacture appear to be adulterated under section 501 of the FD&C Act. Drugs from multiple API manufacturers used by Darmerica were listed on import alerts, including Import Alert 66-40 (IA 66-40) for the manufacturer’s apparent failure to conform with CGMP within the meaning of section 501(a)(2)(B) and Import Alert 66-79 (IA 66-79) for refusing to permit access to or copying of any record as required by section 704(a). To understand whether Darmerica has received any or introduced additional adulterated drugs in interstate commerce, we are requesting information regarding timing of receipt and distribution of drugs from the more than (b)(4) facilities listed below. Darmerica suppliers with drugs listed on IA 66-40 for suppliers’ failure to comply with CGMP: (b)(4) For manufacturers whose drugs are placed on IA 66-40 for failure to conform to CGMP within the meaning of section 501(a)(2)(B), FDA has evidence that the drugs listed in the import alerts appear to be adulterated. You are responsible for ensuring that the drugs you receive and distribute are manufactured in compliance with all relevant CGMP requirements for drugs. Up to date information regarding the import alerts can be found at the following FDA website: https://www.accessdata.fda.gov/cms_ia/ialist.html. Darmerica suppliers with drugs from manufacturers listed on IA 66-79 for refusing to permit access to or copying of any record as required by section 704(a). All drugs from the following facilities appear to be adulterated in that they have been manufactured, processed, packed, or held in a facility and the owner, operator, or agent of such facility delays, denies, or limits an inspection, or refuses to permit entry or inspection. These firms were approved by your firm prior to the March inspection: (b)(4) The following firms approved by your firm failed to respond to the agency’s records request during or after your 2025 inspection: After the FDA inspection, you stated that you improved your supplier qualification program. Yet the following firms that have supplied drugs to Darmerica have been found to be violative since the FDA inspection: (b)(4) In your response, provide the following information: Whether you distributed the drugs from a facility listed above during the time period after the supplier was found to have engaged in the violative activity identified and before any resolution (e.g., removal from an IA). For lots of API received and distributed by Darmerica during the relevant timeframe, indicate whether you have notified your customers that they received adulterated drugs from your firm. If you have not notified any customer who received adulterated drug API from Darmerica, notify them. Include lot identification and recommended actions in your notifications. In your response to this warning letter, provide a copy of that notification and customer acknowledgement. Destruction of Incoming Labels Our investigators observed your firm destroying original labels during API receipt. FDA is concerned that this practice may obscure supply chain information that may be necessary during CGMP investigations, complaints, or other matters. Use of Pre-shipment Samples During our inspection, it was observed that your firm was inappropriately relying on results of quality testing of pre-shipment samples that were shipped directly from the API manufacturer to your third-party laboratory for analysis. For example, your third-party testing laboratory received a sample of a (b)(4) API, (b)(4) , manufacturer’s lot (b)(4) from an API manufacturer for testing on February 27, 2025. However, this same API was not received at your facility until March 3, 2025, four days later. Samples used for the sake of identity testing and evaluation of other quality attributes are to be taken at your facility from containers after receipt from the API manufacturer to ensure they are representative of the API in question and account for the conditions of transport to your facility. For more information about sampling and testing of representative samples to ensure suitability prior to use in repackaging or distribution to customers see FDA’s current guidance document, Questions and Answers on Current Good Manufacturing Practice Requirements | Control of Components and Drug Product Containers and Closures at https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practice-requirements-control-components-and-drug. Importation of Unlisted Drugs Under section 510(j)(1) of the FD&C Act and 21 CFR 207.41(a), a registrant must list each drug that it manufactures, repacks, relabels, or salvages for commercial distribution. As of July 28, 2025, (b)(4) FDA registered manufacturers that identify Darmerica as an importer do not list any drugs with FDA. In numerous instances, Darmerica has attempted to import drugs that are not listed with FDA into the United States. You are responsible for ensuring that the drugs you import are properly listed with FDA. Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Drug registration and listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education. Conclusion The deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations. This letter notifies you of our findings and provides you an opportunity to address them. [B279] [B282] [B84] [B281] [B280] Identify your response with FEI 3012389174 and ATTN: Marva Taylor. Sincerely, /S/ Jill P. Furman, JD Director Office of Compliance Center for Drug Evaluation and Research Content current as of: 12/23/2025 Regulated Product(s)

#### [86] boothwyn-pharmacy-llc-717525-01162026 | issued 01/16/2026 | Boothwyn Pharmacy, LLC | SUBJ: Compounding Pharmacy/Adulterated Drug Products
WARNING LETTER WL # 717525 January 16, 2026 Dear Mr. Howell: From May 12, 2025, to June 9, 2025, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Boothwyn Pharmacy, LLC, located at 221 Gale Lane, Kennett Square, PA 19348. During the inspection, 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 firm on June 9, 2025. FDA acknowledges receipt of your facility’s responses, dated July 1, 2025, and July 31, 2025. FDA further acknowledges that on July 9, 2025, your firm initiated a voluntary recall of all drug products, within expiry, with out-of-specification (OOS) results, including all drug product lots/sub lots that were filled from the same bulk stock solution. FDA also acknowledges that you ceased production of all GLP-1 drug products intended to be sterile and, on August 20, 2025, notified FDA of an intent to resume production of such products. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA). A. [B141] B. Violations of the FDCA Adulterated Drug Products The 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. [B219] [B148] 2. Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces. Additionally, the FDA investigators noted that your firm released and distributed drug products with strengths that differed from their labeled amounts. For example, your Fluorescein 2% Ophthalmic Solution was subpotent (lots # 01242025@ (b)(4) , potency of 85.865% and 03272025@ (b)(4) , potency of 76.1475%). Under section 501(b) of the FDCA [21 U.S.C. § 351(b)], a drug is deemed to be adulterated if it purports to be or is represented as a drug the name of which is recognized in an official compendium and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Accordingly, your Fluorescein 2% Ophthalmic Solution is adulterated under section 501(b) of FDCA. Furthermore, the FDA investigators noted that your firm released and distributed drug products that failed sterility testing. For example, your Tirzepatide 17mg/mL / Glycine 5mg/mL / Methylcobalamin 5mg/mL Injection (lot # 04072025@ (b)(4) ). In addition, the investigators noted that your firm released and distributed drug products with strengths that differed from their labeled amounts. For example, your Semaglutide 2.5mg/mL Injection was subpotent (lot # 03042025@ (b)(4) , potency of 79.876%) and your Tirzepatide 10mg/mL Injection was subpotent (lots # 01172025@ (b)(4) , potency of 86.779% and 02112025@ (b)(4) , potency of 89.13%). 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 Semaglutide 2.5mg/mL Injection and Tirzepatide 10mg/mL Injection are adulterated under section 501(c) of the FDCA. [B151] [B140] Misbranded Drug Products The strength of compounded drugs, for example your Fluorescein 2 % Ophthalmic Solution, Semaglutide 2.5mg/mL Injection, and Tirzepatide 10mg/mL Injection, differed from and fell below their labeled strength. Under section 502(a) of the FDCA [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Because the labeling of these drug products is false or misleading, they are misbranded under section 502(a) of the FDCA. The introduction or delivery for introduction into interstate commerce of these drug products therefore violates 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 firm’s responses to the Form FDA 483. We further acknowledge that on July 9, 2025, your firm initiated a voluntary recall of all drug products, within expiry, with OOS results, including all drug product lots/sub lots that were filled from the same bulk stock solution. We also acknowledge that you ceased production of all GLP-1 drug products intended to be sterile and, on August 20, 2025, notified FDA of an intent to resume production of such products. Regarding your responses related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation: 1. Regarding the repeat deficiencies identified in your smoke studies, your firm indicated that new smoke studies were performed on 07/30/2025 using protocols PCL-07303025-1 and PCL-07303025-2. However, you did not provide copies of these protocols and the corresponding new smoke studies. Without this supporting documentation, your firm’s assertion that the new smoke studies demonstrate and reflect the following corrective actions cannot be verified: a. “Updated smoke studies will clearly demonstrate that ISO 5 air is not compromised by air entering from the surrounding ISO 7 zone, using improved camera positioning and multiple angles to ensure complete visibility of the airflow boundary.” b. “Studies will accurately reflect production practices, including the appropriate use of one or more operators when applicable, and all roles and workflows will be documented and aligned with routine compounding procedures.” c. “First air protection over critical items such as bulk solution containers, stopper trays, and vial caps will be explicitly visualized, with clear footage showing that airflow remains unidirectional and undisturbed across all critical points.” d. “The issues observed in videos from BSC [Biological Safety Cabinet] units CEC#01983 and CEC#02166, such as stagnant airflow, arched patterns, backflow, and handling techniques, will be rectified by updated studies conducted under revised aseptic workflows. Technician retraining and procedural modifications have already begun to address these technique-related risks.” e. “[Camera] positioning and lighting have been optimized to ensure that first pass air is clearly visible over all active work areas, with no blind spots during critical manipulations.” In addition, you provided aseptic visual aids (Exhibit 12a - Aseptic Visual Aids, Pg. 79) that depicted airflow patterns in the ISO 5 BSC. These visual aids showed turbulence and no first air observed in the central area near the work surface (or deck) due to the air being pulled by the front and back vents inside the BSC. Given that your firm produces the majority of drug products intended to be sterile on the deck of a BSC, it remains unclear whether your firm has assessed and modified your aseptic procedures to adequately address this airflow deficiency. 2. Regarding your production areas having surfaces that are difficult to clean or contain porous, particle generating surfaces, your firm provided several documents: the reconstruction floor plan for the remodeling of (b)(4) cleanroom suite, the construction proposal and repairs punch list, and images of the ceiling tiles and walls of the newly remodeled area still under construction. However, you did not include adequate information or supporting documentation for review, including but not limited to: a. Specification documentation of the ceiling tiles used in the remodel; b. Documentation demonstrating these tiles are suitable for pharmaceutical use and cleaning protocols; c. Updated cleanroom certification report; and d. Environmental monitoring data for the remodeled cleanroom suite. Based on the images provided in your responses, it is unclear whether the ceiling tiles were properly caulked or if gaps exist between the ceiling tiles. Additionally, it remains unclear whether these newly constructed cleanroom areas meet the standards required to support the resumption of sterile production. While your responses indicate that the original interior walls in rooms (b)(4) and (b)(4) were replaced with (b)(4) (including in the newly created room (b)(4) ), insufficient information or supporting documentation were provided for review, including but not limited to: a. Specification documentation for the (b)(4) ; and b. Documentation demonstrating that these (b)(4) are appropriate for pharmaceutical use and cleaning. Regarding your responses related to other adulteration issues, the following corrective actions appear deficient: 1. Regarding your firm releasing drug products where strength differs from, or quality or purity falls below, that which the products purport or are represented to possess, your firm’s Standard Operating Procedures (SOP) contain conflicting provisions regarding release of drug products intended to be sterile prior to receiving final sterility testing results raising significant concerns about product quality and patient safety. In your response, you provided SOP ID: CP.GENCMPD.016.001 Compounded Sterile Preparation Batch Release which states, “Any human sterile preparation shall not be released until passing sterility and endotoxin results are received and approved." However, section 6.5.1 of the same SOP states, “CSP [ophthalmic] may be released for dispensing 'at risk' prior to receiving the final sterility test results.” These two statements in the same SOP appear to be contradictory, and you have not provided any scientific justification for releasing ophthalmic drug products intended to be sterile prior to receiving the final sterility test results, nor clarified whether patients or prescribers will be notified of the “at risk” status. This concern is heightened given your firm’s documented history of sterility failures of drug products intended to be sterile, where patients were not notified of these failures. Furthermore, SOP ID: CP.GENCMPD.016.002 Batch Release Record, section 6.4.2 states, “If risk release is authorized by patient or prescriber, the Lab pharmacist may retrieve the products required for that specific RX from the designated hold area.” This provision indicates that any sterile drug product may be released “at risk”, without limiting this practice to ophthalmic preparations or excluding other categories of human drug products intended to be sterile. Additionally, the procedure does not specify whether you would inform the prescribers or patients in cases where the drug product subsequently fails sterility testing. Based on these SOPs, your firm's actual policy for “at risk” product release remains unclear, creating potential compliance issues and patient safety risks. You acknowledged that the release of compounded preparations that were OOS “reflects a deviation from [your] internal quality assurance procedures and [your] obligation to notify patients and prescribers upon discovery of any compromise to product strength, sterility, or potency.” However, you did not provide corrective actions addressing this deviation for failure to notify patients and prescribers when OOS’s were identified. Section 6.8 SOP ID: CP.GENCMPD.016.001 states, “Any OOS results must be immediately reported to quality and the pharmacist-in-charge. Investigation and root cause analysis should be performed when applicable per SOP QA.CAPA.016.001 Variance and OOS Investigations. A recall and customer notification procedures shall be followed when applicable.” This language indicates that investigation, root cause analysis, recall, and customer notification are only required "when applicable” rather than for every OOS occurrence. In addition, the SOP lacks defined timeframes for both patient/prescriber notification and investigation procedures following OOS occurrences. In addition, during the inspection, investigators reviewed 23 variance/OOS investigation reports from November 2024 through May 2025; none of these reports followed your SOP for investigating OOS results, and none of the investigations included documentation of contacting the patient by your firm. Of these 23, nineteen variance/OOS investigations remained open at the time of the inspection. It remains unclear whether these variance/OOS investigation reports have since been closed and whether the affected patients and/or their healthcare providers have been notified. There is no assurance that you will adhere to your own SOP procedures moving forward. Your responses did not identify or discuss the root cause(s) for the numerous sterility and potency OOS results for your drug products intended to be sterile. Between July 2, 2024 and May 1, 2025, your firm distributed drug products intended to be sterile that failed to meet sterility and potency specifications, including 9 lots with sterility failures and approximately 25 lots with potency failures (for human use). Given the substantial number of OOS results at your facility, particularly potency failures, section 6.1.2 of your SOP ID: CP.GENCMPD.016.001 Compounded Sterile Preparation Batch Release states: “Any lots that are sent out for potency testing shall be held in Quality hold. They shall only be released for dispensing once passing potency results are received.” However, this section suggests you conduct potency testing on a selective basis rather than testing every lot or sub lot that is produced. Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A. [B150] [B155] [B250] D. [B126] [B2] [B20] [B153] [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. [B17] [B0] [B16] If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time in which you will do so. [B251] In your response, refer to the Warning Letter Number above (# 717525) 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 Content current as of: 02/10/2026 Regulated Product(s)