K.C. Pharmaceuticals Inc. – FDA Warning Letter, Feb 13, 2023

The FDA inspected K.C. Pharmaceuticals Inc. from January 18-27, 2023, and February 10-13, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Failure to prevent microbiological contamination (21 CFR 211.113(b)):** * **Inadequate Smoke Studies:** Smoke studies for aseptic processing lines were not performed under adequate dynamic manufacturing conditions, with commercial manufacturing starting on one line in 2020 without sufficient studies. A repeat observation, the firm's response was inadequate due to a lack of detailed product impact assessment. * **Incomplete Media Fill Failure Investigations:** Multiple media fill failures since 2020 on both lines had incomplete investigations or were invalidated without adequate scientific justification.

2. **Inadequate facility design to prevent contamination (21 CFR 211.42(c)(10)):** * **Insufficient Building Management Systems (BMS):** Lack of continuous monitoring and recording of differential pressures; manual recording frequency was inadequate. * **Compromised Aseptic Processing Line:** The ISO 5 aseptic processing line had open ports to the surrounding room, and operators were observed reaching through these ports instead of using installed gloves during aseptic processing and smoke studies.

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