Sun Pharmaceutical Industries Inc – FDA Warning Letter, Apr 28, 2010

The FDA issued a Warning Letter to Sun Pharmaceutical Industries, Inc. following a February 25 - April 28, 2010 inspection of their Cranbury, NJ facility, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. The firm's May 18, 2010 response was deemed insufficient.

Key violations include: 1. **Inadequate Production and Process Controls (21 C.F.R. § 211.100(a)):** The manufacturing process for Gemfibrozil Tablets, 600 mg, was not in a state of control, exhibiting "sticking and picking" defects, OOS results for impurities, and imploding retain samples. The firm used Magnesium Stearate from an unqualified supplier. Corrective actions were inadequate, lacking plans for distributed products and supplier qualification. 2. **Insufficient Investigations of Failures (21 C.F.R. § 211.192):** The firm failed to thoroughly investigate imploding Gemfibrozil bottles since September 2009, delaying recall and root-cause analysis. OOS water content results for Promethazine HCl Tablets, 25 mg, were invalidated without an assignable laboratory cause, and investigations were not extended to associated batches. 3. **Failure of Quality Control Unit (QCU) Responsibilities (21 C.F