FDA WARNING_LETTER - System Kosmetik Produktionsgesellschaft fur kosmetische Gmbh - February 18, 2022

On September 9, 2022, the FDA issued a Warning Letter to System Kosmetik Produktionsgesellschaft fur kosmetische Gmbh following an inspection from February 16-18, 2022. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Production and Process Controls (21 CFR 211.100(a) and 211.67(b)):** The firm failed to validate manufacturing processes for OTC drug products, lacking documentation, qualification protocols, and studies. Batch records were inadequate, missing critical production information like mixing times and in-process checks. Bulk hold time studies were also absent. The firm uses the same equipment for pharmaceutical and non-pharmaceutical products, with insufficient cleaning validation, posing cross-contamination risks. 2. **Insufficient Laboratory Controls (21 CFR 211.160(b)):** The firm's water system failed to consistently meet USP specifications, with high microbial counts. There was no specification or testing for total organic carbon (TOC) in the water. 3. **Failure to Test Incoming APIs (21 CFR 211.84(d)(1)):** The firm did not perform identity testing on incoming