FDA 483 - Jubilant Generics Limited - February 02, 2024

The FDA Form 483 details multiple observations from an inspection, primarily concerning quality control, investigation procedures, and manufacturing processes.

**Key Violations and Observations:**

* **Inadequate Investigations:** The firm failed to consistently make written records of investigations into unexplained discrepancies. Specifically, a cleaning verification protocol (PR-CV-22-0021) revealed unknown extraneous peaks during residue testing of swab samples. A deviation investigation (PR# 206993) was opened, but the root cause for out-of-specification (OOS) results for REDACTED residue (PR#212885) was not identified even after Phase 1 and Phase 2 investigations. Two extraneous peaks were attributed to REDACTED and REDACTED via LC-MS, but their presence in cleaning verification swab samples lacked a root cause and corrective actions. Other extraneous peaks remained unidentified. Affected lots (REDACTED and REDACTED) were distributed to the US market. The cleaning verification report (RR-CV-23-0007) failed to mention these deviations or OOS investigations, yet concluded the cleaning procedure was effective. This indicates deficient and unreliable cleaning validation/verification, with inadequate impact assessment and CAPA. Approximately REDACTED batches of REDACTED Tablets USP have been released since January 2022. * **Quality Control Unit Deficiencies:** Responsibilities and procedures for the quality control unit were