FDA 483 - Ipca Laboratories Limited - June 23, 2023

This FDA Form 483 details observations from an inspection, highlighting significant quality system and manufacturing deficiencies.

**Facility and Operations:** The inspection covered a facility manufacturing various tablet drug products for both US and non-US markets.

**Violations and Observations:**

1. **Failure to Thoroughly Review Discrepancies (21 CFR 211.192):** * **OOS Dissolution (12/2/2022):** An Out-of-Specification (OOS) result for tablet dissolution (Batch No. non-US market) was invalidated based on inconclusive hypothesis testing and retesting, without identifying a clear root cause for the initial OOS. The investigation hypothesized "improper" as the cause, but verification yielded inconsistent results. * **OOS Assay (12/5/2022):** An OOS result for tablet assay (Batch No. non-US market) was invalidated. The investigation suspected "improper" at the sample preparation stage, concluding "error in" as the root cause based on retesting. However, the investigation failed to explain why this would cause a significantly higher assay value or verify the "improper" condition. * **OOS Assay (11/29/2021):** An OOS result for tablet assay (Batch No. non-US market) was invalidated. The investigation suspected sample