FDA WARNING_LETTER - OMEZA LLC - July 28, 2023

On December 12, 2023, the FDA issued a Warning Letter to Omeza LLC following an inspection from July 24-28, 2023, at their Sarasota, Florida drug manufacturing facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Facility Sanitation (21 CFR 211.56(a)):** Mold-like substance was found on an air conditioning unit sleeve above the manufacturing area, and live/dead insects and animal waste were observed in bulk drug product storage. The firm's response was inadequate, lacking environmental monitoring review, risk analysis of previously manufactured products, and testing of reserve samples. 2. **Component Testing (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm failed to perform identity testing on incoming components (e.g., cod liver oil) and did not validate supplier test analyses for components like lidocaine. The response was inadequate, lacking a retrospective review of distributed products and detailed testing requirements for supplier qualification. 3. **Stability Testing (21 CFR 211.16