FDA 483 - Sun Pharmaceutical Industries Limited - November 16, 2016

This FDA Form 483 details multiple observations from an inspection.

**Facility and Operations:** The inspection involved a facility manufacturing REDACTED tablets REDACTED mg and REDACTED mg.

**Violations and Observations:**

1. **Failure to Thoroughly Review Batch Failures:** * OOS investigation #217272 for REDACTED tablets REDACTED mg (batch REDACTED) showed a failing related substance test (REDACTED% vs. NMT REDACTED%). Three associated batches (A REDACTED, H REDACTED) also failed. * Despite no laboratory error, a non-assignable cause was identified. Batches were released in March 2016. * The impurity specification for REDACTED was changed post-OOS results to align with EP pharmacopoeia, justifying batch release. * SOP HQP013156 (Handling of Out of Specification Results) requires batch rejection if OOS is valid. * OOS investigation #221781 for REDACTED tablets REDACTED mg and REDACTED mg (batches REDACTED, REDACTED) concerned IR test identification. The analyst was untrained in IR identification for finished product testing of REDACTED tablets.

2. **Incomplete Laboratory Records:** * The AAS equipment logbook did not show repeat