FDA WARNING_LETTER - Firson Co., Ltd. - November 11, 2016

The FDA issued a Warning Letter to Firson Co. Ltd. following an inspection from November 3-11, 2016, identifying significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to prevent microbiological contamination (21 CFR 211.113(b)):** Inadequate media fills lacked sufficient frequency, worst-case simulation, and proper documentation. Smoke studies were deficient, failing to evaluate dynamic conditions and aseptic interventions. Sterilization processes for drug products were not robust, with insufficient lethality and lack of critical batch record information. The FDA requested a comprehensive review of the media fill program, sterilization validation, environmental monitoring, and dynamic smoke studies, along with an action plan for corrective actions, including potential recalls of affected products. 2. **Failure to thoroughly investigate discrepancies (21 CFR 211.192):** The firm failed to adequately investigate 32 customer complaints regarding irritation, burning, pain, and discharge from their drug products. Investigations were insufficient, lacking evaluation of manufacturing processes and routine sterility testing. The FDA requested remediation of the complaint investigation process and summaries of all investigations since January 2016. 3. **Failure to establish adequate laboratory controls (21 CFR 211.160(b)):** The identification test procedure for incoming raw materials, specifically (