USFDA 483 to IPCA, Silvassa Cites Lapses in Failure Investigations, CAPA Implementation

FDA has published the USFDA form 483 issued to Ipca Laboratories Ltd following inspection at the Silvassa facility (FEI 3005977675) from April 18 to April 26, 2023. Key observations include Deficiencies in failure investigations, Lapses in implementing timely corrective and preventive actions (CAPAs), Low priority on addressing significant compliance issues including data integrity lapses. The site was inspected by USFDA Investigators Rajiv R. Srivastava and Kellia N. Hicks.

1. Deficiencies in Failure Investigations:
   • The inspection revealed significant failures in investigating unexplained discrepancies. Specifically, Out of Specification (OOS) and Out of Trend (OOT) results were invalidated, and samples were retested without conducting the necessary Phase IIA (Manufacturing Investigation) or providing scientifically justified root causes.
   • In a market complaint investigation regarding spots on tablets, the investigation failed to rule out contamination from the HVAC system.
2. Lapses in Timely Implementation of Corrective and Preventive Actions (CAPAs):
   • There were notable delays in documenting and closing issues, including a tablet inspection system that remained unresolved for over 10 months.
   • A CAPA related to revising a test method was not implemented for more than 7 months.
   • The firm repeatedly identified similar human error as the root cause for dissolution testing failures, indicating a lack of effective corrective measures.
3. Inadequate Quality System and Oversight:
   • The quality system and quality unit did not adequately ensure the accuracy and integrity of data, lacking sufficient oversight and assurance of drug product quality.
   • A change control related to an HMI system, which lacked audit trail and has lost quality related data irretrievably, remained open for over four months.
   • Several non-readable printouts from a balance in the Microbiology lab were reviewed and signed by the Microbiologist, Supervisor, and Quality Assurance without any corrective action taken.

IPCA Silvassa USFDA 483 (April 2023)