FDA WARNING_LETTER - Optikem International Inc. - January 26, 2024

The FDA issued a Warning Letter to Optikem International Inc. following a January 17-26, 2024, inspection of their Denver, CO, drug manufacturing facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Aseptic Processing Areas (21 CFR 211.42(c)(10)):** The facility's cleanroom and processing line, used for sterile ophthalmic drugs, were inadequately designed and maintained, with issues like particle board, rust, chipping paint, damaged chairs, and gaps in the ceiling. Environmental monitoring was insufficient, with infrequent testing, inadequate incubation parameters, and repeat microbial recoveries. Airflow qualification was also deficient. 2. **Failure to Prevent Microbiological Contamination (21 CFR 211.113(b)):** The firm produced sterile drugs without adequate process simulations (media fills), failed to perform routine media fills, and exhibited poor aseptic technique and cleanroom behavior among operators. Sterilization of equipment surfaces was also inadequate. 3. **Inadequate Production and Process Controls (21 CFR 211.100(a)):** The manufacturing processes for sterile ophthalmic drugs and the water system used in formulation were not adequately validated. 4. **Insufficient Laboratory Controls (21 CFR 211.160