FDA WARNING_LETTER - Cosmecca Korea Co., Ltd. - September 22, 2017

The FDA issued a Warning Letter to Cosmecca Korea Co., Ltd. following an inspection from September 18-22, 2017, identifying significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to test drug products prior to release (21 CFR 211.165(a)):** The firm released OTC drug products without supporting analytical data for conformance to specifications, and a lab personnel admitted not testing every lot. 2. **Incomplete laboratory records and data falsification (21 CFR 211.194(a)):** An investigator documented multiple instances of falsified laboratory records, with a quality control employee admitting to manipulating electronic data for untested products. The firm's response indicated the quality assurance manager instructed this manipulation. 3. **Quality control unit failure to review and approve records (21 CFR 211.192):** Batch records for an OTC sunscreen product contained inaccurate concentration values for active ingredients, leading to the release of an out-of-specification (superpotent) lot. 4. **Inadequate controls over computer systems (21 CFR 211.68(b)):** Laboratory equipment lacked restricted access, with shared usernames/passwords and administrator rights, preventing traceability of data changes. 5. **Failure to establish