FDA 483 - Sun Pharmaceuticals Industries Ltd. - December 15, 2023

This FDA Form 483 details five observations from an inspection.

**Observation 1:** Failure to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. Specifically, long-term stability sample failures for drug products sold in the US market were not adequately investigated. For example, OOS Investigation PR ID #724426 for Product: (b)(4) Tablets (b)(4) mg/(b)(4) mg, Batch Number: (b)(4), regarding dissolution failure, concluded a detached dissolution basket based on analyst interviews. However, the Quality Unit restricted the investigation of falsified Dissolution Parameter Checklists to only the failing batch, not extending it to other batches analyzed by the same QC Analysts on the same day. No scientific justification was provided for the QC Analyst's failure to report a missing basket. Additionally, OOS investigations for Related Substance by HPLC, such as PR ID: 1502090, were not thoroughly investigated, with no assignable root cause identified and a probable sample solution preparation error concluded without ruling out other possibilities.

**Observation 2:** Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination. Approximately 450 mL of stagnant liquid was observed in the Air Purification Unit (APU) (ID: GPN/EQ/285), with chemical analysis showing the presence of (b)(4) API and impurities, indicating potential cross-contamination