FDA WARNING_LETTER - Teva Parenterals Medicines, Inc. - July 24, 2009

This Warning Letter, dated December 11, 2009, was issued to Teva Parenteral Medicines, Inc. following a July 13-24, 2009 inspection of their Irvine, CA facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) Regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Failure to test components for microbiological contamination:** Specifically, raw materials for Propofol Injectable Emulsion were not tested for bacterial endotoxin. 2. **Inadequate investigation of discrepancies:** The firm failed to identify root causes for out-of-specification endotoxin levels in Propofol lots, including a recalled lot, and did not adequately investigate water contamination in vials or chipped lip vials, failing to extend investigations to other potentially affected batches. 3. **Inadequate acceptance criteria for sampling:** The finished product sampling plan for Propofol was not statistically representative of batch sizes. 4. **Failure to test in-process materials:** In-process non-sterile bulk solution and end-of-run samples were not tested for bacterial endotoxin. 5. **Inadequate bacterial endotoxin test methods:** Deficiencies in vortexing, pH adjustment, and vibration protection for testing equipment were noted. 6. **Failure to demonstrate appropriate equipment design:** Validation of