FDA 483 - Piramal Pharma Limited - February 17, 2025

This FDA Form 483 details observations from an inspection conducted on February 11, 2025, concerning the manufacturing of Active Pharmaceutical Ingredients (APIs).

**Observation 1** highlights deficiencies in the quality control unit's written procedures and adherence. A material storage room was observed with material on the floor and leaking from a vessel, with no operator present or documentation of activity. Equipment logbooks and line clearance checklists lacked checks for vessel gaskets, and timeframes were not appropriately documented. Dispensing material weight sheets and line clearance checklists were improperly stored within executed batch manufacturing records (BMRs). Furthermore, the software controlling API processes reported numerous uninvestigated and unacknowledged alarms across multiple batches, including critical "stop the device" alarms, and equipment alarms were not challenged during IQ/OQ/PQ.

**Observation 2** addresses inadequate follow-up in written records of API investigations. Four deviations for "stuck" batches were reported, but no documented quality risk assessment was performed for continued manufacturing on the same equipment while investigations were open. An investigation for one batch was opened only after the decision to manufacture the next batch on the same equipment, which subsequently experienced a similar deviation. There was no documentation of service or engineering activities for repeated issues, and affected batches were not evaluated for stability despite process deviations.

**Observation 3** points to insufficient follow-up in API complaint investigations. For Customer Complaint CC-22-06 regarding foreign