FDA WARNING_LETTER - Cadila Pharmaceuticals Limited - March 28, 2014

This FDA Warning Letter, dated February 25, 2015, to Cadila Pharmaceuticals Limited, details significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs) observed during a March 24-28, 2014 inspection of their Ankleshwar, India facility. These deviations render their APIs adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Complaint Investigations:** Failure to fully investigate complaints and extend investigations to affected batches since 2011. Examples cited include an unpleasant odor complaint for (b)(4) API in September 2011, where corrective actions were not implemented before closing the investigation, and an August 2012 complaint for odor and out-of-specification (OOS) unknown impurity in (b)(4) API, where supporting data was not retained or showed discrepancies, and the quality unit failed to recognize the OOS prior to release. 2. **Quality Unit Deficiencies:** The quality unit failed to ensure APIs complied with CGMP and met specifications. For instance, (b)(4) API batch (b)(4) was released with an unknown peak in the residual solvents chromatogram, later identified as contamination, which analysts and supervisors failed to notice or evaluate. 3. **Data Integrity Issues:** Failure to prevent unauthorized access