Cosmax USA, Inc. – FDA Warning Letter, Mar 17, 2020

The FDA issued a Warning Letter to Cosmax USA, Inc. following an inspection from February 24 to March 17, 2020, at their Solon, Ohio drug manufacturing facility. The inspection revealed 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. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate microbial out-of-limit (OOL) results in their water system, including the repeated identification of *Pseudomonas aeruginosa* and other OOL results. Investigations lacked root cause analysis and microorganism identification, and the impact on distributed drug products was not addressed. 2. **Lack of Production Phase Time Limits (21 CFR 211.111):** The firm lacked bulk hold time studies for drug products held at the in-process stage for up to six months, assigning a maximum hold time without an approved study or protocol, and exceeding it without investigation. 3. **Inadequate Cleaning Procedures (21 CFR 211.67(b)):** Employees failed to follow written cleaning and sanitization procedures for non-dedicated production tanks, including temperature and fill level requirements. Documentation was inadequate, and procedures lacked details for cleaning difficult-to