WARNING LETTER Acino Products, LLC MARCS-CMS 589471 — FEBRUARY 10, 2020
3. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
When requested, your firm could not provide test results to support the microbiological testing results on your certificate of analysis (COA) for bisacodyl and phenylephrine suppositories, yet your firm signed the COA indicating conforming results for microbiological testing and released the batches. During the inspection, you also could not explain whether samples had been sent to your third-party lab for analysis to support the results on your COA.
Your response stated that, going forward, no COA will be signed without receipt of the actual results, but did not include information about the review and management data to support release of your drug products.
In response to this letter, provide:
• A list of chemical and microbial test methods and specifications used to analyze each lot of your drug products before a lot disposition decision, including but not limited to impurities testing for clotrimazole topical solution.
• A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
• A list of chemical and microbial test methods and specifications used to analyze each lot of your drug products before a lot disposition decision, including but not limited to impurities testing for clotrimazole topical solution.
• A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119570/download.
