FDA WARNING_LETTER - Nowcos Co., Ltd - August 04, 2017

The FDA issued a Warning Letter to Nowcos Co., Ltd. following an inspection from July 31 to August 4, 2017, at their drug manufacturing facility in Sejong-Si, South Korea. The letter identifies significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. Failure to establish written procedures for production and process control, specifically lacking validation for OTC drug product manufacturing processes, process qualification studies, and an ongoing process control monitoring program (21 CFR 211.100(a)). 2. Failure to establish adequate laboratory controls, including unvalidated test methods, lack of procedures for raw material and finished product sampling, and no growth promotion testing for microbial media (21 CFR 211.160(b)). 3. Failure to establish and follow adequate written procedures for equipment cleaning and maintenance, with no cleaning validation studies for non-dedicated production equipment to prevent cross-contamination (21 CFR 211.67(b)). 4. Failure to establish and follow an adequate written testing program for drug product stability, resulting in inadequate stability studies to ensure products remain within specification throughout their labeled expiry (21 CFR 211.166(a)).

The FDA noted