FDA WARNING_LETTER - Cipla Limited - September 27, 2019

The FDA issued a Warning Letter to Cipla Limited, Mumbai, India, following an inspection of their Verna, Goa drug manufacturing facility from September 16-27, 2019. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Equipment Cleaning (21 CFR 211.67(a)):** Investigators found residues of different products in exhaust ducts and confirmed cross-contamination of active ingredients in subsequent batches (e.g., [b][4] active ingredient in [b][4] tablets). The firm's response was deemed inadequate, lacking a clear root cause and comprehensive assessment of contamination scope. Required actions include a comprehensive, independent retrospective assessment of cleaning effectiveness, a CAPA plan for cleaning processes, and an updated cleaning validation program.

2. **Failure to Thoroughly Investigate Discrepancies (21 CFR 211.192):** The firm failed to adequately investigate numerous HEPA filter failures in late 2018, which compromised aseptic conditions. Approximately 80 batches for the U.S. market were potentially impacted. The investigation lacked sufficient data to assess the impact on marketed batches and address environmental monitoring excursions. Required actions include a comprehensive, independent