FDA 483 - Torrent Pharmaceuticals Limited - April 28, 2017

The FDA Form 483 details several deficiencies in the quality unit's adherence to responsibilities and procedures.

**Change Control Program Deficiencies:** * **Untimely Closure:** Numerous change control records from 2011-2014 (3 to 226 records, respectively) remained open, violating SOP CQA-055, Version 4.0, which mandates timely closure and periodic review by the Head of Quality. No final action was taken for unimplemented changes, nor was a final assessment made for implemented ones. * **Uninitiated Change Control:** A change control record was not initiated for an update to Stability Study Data Sheet RL/73476/01, which revised instructions for pH meter calibration in dissolution testing.

**Batch Record Review Deficiencies by Quality Assurance (QA):** * **Unexplained Discrepancies:** A production batch record for a Stage Batch contained disregarded weight printouts (dated 16 OCT 16) without explanation, and the acceptance of later printouts (18 OCT 16) was not justified. Incorrect weights were not crossed out, and QA approved the record without noting or correcting these issues. * **Missing Page/Unverified Data:** A production batch record for a Finished API batch was missing a page. Operator-recorded results on the back of page 44 were not signed as reviewed or verified by QA, despite a deviation