Apothecary Pharma, LLC
7 extracted findings · 5 model-assigned issue types
FDA source excerpt, selected passage
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).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Drug products lack adequate directions for use, causing misbranding under section 502(f)(1).
Supporting FDA text
Source excerpt · automated text-match checkyour 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).
Quality control unit lacks written responsibilities and procedures, and failed to follow them.
Supporting FDA text
Source excerpt · automated text-match checkYour 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)).
Inadequate system for maintaining equipment used to control aseptic conditions.
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)).
Inadequate system for cleaning and disinfecting room and equipment to produce aseptic conditions.
Supporting FDA text
Source excerpt · automated text-match checkYour 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)).
Batch production and control records lack complete information.
Supporting FDA text
Source excerpt · automated text-match checkYour 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).
Manufacturing personnel did not wear appropriate clothing to protect drug product from contamination.
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)).
Inadequate smoke studies under dynamic conditions to demonstrate unidirectional airflow in ISO 5 area.
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
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What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Provide competency verification or supervisory oversight of retrained inspectors, and a retrospective review of batches inspected under improper techniques.
- Provide a retrospective review plan for released batches (b)(4), (b)(4) and a root cause analysis for why incomplete records were initially released.
- Provide training records demonstrating staff understanding of the new SOP 1012.00 procedures and evidence that the enhanced batch record review process addresses all identified deficiencies.
- Provide an assessment of previously released products manufactured in potentially uncertified environments.
- Provide detailed protocols to ensure dynamic smoke studies simulate true production with maximum equipment and personnel, and define acceptance criteria or Quality Unit oversight for vendor-conducted studies.
- Conduct a risk assessment for the (b)(4) Tirzepatide 10 mg/mL batches released without validated airflow studies, and provide an impact evaluation or justification for their release.
- Propose workspace/equipment modifications to ensure all vials receive unidirectional airflow, and evaluate equipment configurations to mitigate this risk.
- Provide essential supporting documentation such as photographic evidence, maintenance records, or updated SOPs, and specify repair methods for rust damage, including interim controls or monitoring to mitigate contamination risk while the compromised LAFH remained in service, including upon resumption of operations on August 1, 2025, and provide supporting documentation including photographs, maintenance records, engineering assessments, updated SOPs, or qualification protocols to demonstrate implementation and effectiveness of proposed changes.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.