FDA WARNING_LETTER - EUGIA Pharma Specialities Limited - February 02, 2024

On August 15, 2024, the FDA issued a Warning Letter to Eugia Pharma Specialities Limited (Unit III) following an inspection from January 22 to February 2, 2024. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Incomplete Laboratory Records (21 CFR 211.194(a)):** Failure to ensure complete and accurate data for production and process simulations, including observed instances of operators not testing all required components and falsifying environmental monitoring records for ISO 5 and ISO 7 areas. Systemic data integrity issues involved numerous staff over months. 2. **Incomplete Batch Production and Control Records (21 CFR 211.188):** Operators documented cleaning and sterilization activities for equipment that were not performed, and failed to follow SOPs for other cleaning tasks. 3. **Failure to Prevent Microbiological Contamination (21 CFR 211.113(b)):** Operators did not follow aseptic procedures, performing unnecessary interventions, directly contacting the filling line, blocking airflow, and failing to clear impacted vials. Inadequate documentation and underreporting of interventions were also noted. 4. **Inadequate Investigations (21 CFR 211.1