FDA 483 - Dr. Reddy's Laboratories Limited CTO VI - January 28, 2020

This FDA Form 483 details observations from an inspection, highlighting significant deficiencies in process validation, investigation procedures, cleaning validation, trend analysis, and quality unit oversight.

**Process Validation:** The validation for REDACTED is inadequate, evidenced by REDACTED Out of Specification (OOS) results for Residual Solvents (RS) in commercial batches between December 2017 and December 2019. These batches had REDACTED content exceeding the NMT REDACTED ppm specification. Despite a November 2019 investigation (OOS # 310018090) concluding a rectified issue and "no impact on further batches," subsequent batches (REDACTED) also failed. Recurrent failures for REDACTED residual solvent in both process validation and commercial batches persist without scientifically justified root cause analysis.

**Investigations:** Investigations for OOS and incidents are inadequate. For example, OOS # 310018104 and Incident # 200338632 for REDACTED batch REDACTED initially attributed failure to human error, but subsequent release testing revealed OOS for solubility and residual solvent. OOS # 310017867 for REDACTED batch # REDACTED, concerning REDACTED impurity, only involved a laboratory investigation, without evaluating manufacturing. OOS # 310016984 for REDACTED batch