FDA WARNING_LETTER - Catalent Pharma Solutions - November 15, 2007

An FDA inspection of Catalent Pharma Solutions (Raleigh, NC) from November 6-15, 2007, revealed significant deviations from current Good Manufacturing Practice (CGMP) in the manufacture of [redacted], violating Section 501(a)(2)(B) of the FD&C Act and 21 CFR Parts 210 and 211.

Key violations include: 1. **Inadequate Quality Control Unit Investigations (21 CFR 211.192):** Failure to thoroughly investigate discrepancies, identify trends for environmental excursions (July-November 2007), and ensure timely completion of corrective actions (e.g., purified water loop heat exchanger not ordered, microbial identification delays). 2. **Insufficient Aseptic Processing Controls (21 CFR 211.42(c)(10)(v)):** Delayed systematic facility cleaning for mold despite prolonged environmental excursions, and lack of disinfectant effectiveness studies against representative microorganisms. 3. **Failure to Follow Sterile Product Procedures (21 CFR 211.113(b)):** Incomplete monitoring of Water for Injection use points, unreviewed environmental monitoring data by the quality unit, and failure to notify personnel of environmental monitoring excursions. 4. **Unvalidated Test Methods (21 CFR 211.165(e)):** Sterility test method STR-MTM