Intas Pharmaceuticals Limited – FDA Warning Letter, May 12, 2023

The FDA issued a Warning Letter to Intas Pharmaceuticals Limited following an inspection from May 1 to May 12, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Quality Control Unit Failure (21 CFR 211.22):** The quality control unit failed to ensure drug products complied with CGMP and specifications. Visual inspectors manipulated particle and defect counts on manual visual inspection records since 2021 to keep batches within rejection limits, indicating significant data integrity deficiencies and a lack of QA oversight. The firm's response was inadequate, lacking a comprehensive evaluation of other CGMP records and a systematic CAPA plan. 2. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate unexplained discrepancies or failures. Investigations into visual inspection failures and non-viable particulates (NVP) exceeding action levels were insufficient, lacking scientifically supported root causes. The firm's response was inadequate, as it did not commit to appropriate definition and categorization of particulates or address the inappropriate timeframe for NVP deviation initiation. 3. **Inadequate Production and Process Controls (21 CFR 211.100(a)):** Personnel qualification for visual inspection was deficient due to inadequate challenge test kits. The manufacturing process for (b)(4) mg (b)(4) tablets lacked adequate validation