Apothecary Pharma, LLC — FDA Warning Letter Findings

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.

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.

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…

Production areas or equipment have difficult to clean and visibly rusty equipment or surfaces.

Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)).

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.

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…

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…

Lack of disinfection of equipment and supplies at each transition from areas of lower quality air to areas of higher quality air.

Personnel moved quickly in a critical area such that unidirectional airflow is likely to be disrupted.

Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)).

Personnel engaged in aseptic processing while exposing skin within the ISO 5 aseptic processing area.

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.

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, Code of Federal Regulations (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 a definition of what constitutes a “serious” and…

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.

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). Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for…

An operator blocked first air by placing gloved hands directly over open sterile containers.

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…

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)).

Your firm failed to establish and 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)).

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…

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…

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.

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.

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)).

Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.