Windlas Healthcare Private Limited – FDA Warning Letter, Aug 30, 2019

The FDA issued a Warning Letter to Windlas Healthcare Private Limited following an inspection from August 26-30, 2019, identifying significant CGMP violations, rendering their drugs adulterated.

Key violations include: 1. **Incomplete Laboratory Records (21 CFR 211.194(a)):** The firm failed to maintain complete and accurate data. Examples include disabling peak detection during GC testing, leading to unreported unknown impurity peaks in API used for U.S. market products, and invalidating multiple OOS results for related substances testing without adequate investigation, ultimately reporting passing data after repeated failures. 2. **Inadequate Investigation of Discrepancies (21 CFR 211.192):** The firm failed to thoroughly investigate unexplained discrepancies or batch failures. Numerous laboratory incident (LI) investigations lacked scientific rationale for root cause determination, leading to invalidation of failing OOS results and subsequent reporting of passing retest results. 3. **Inadequate Quality Control Unit (21 CFR 211.22(a)):** The Quality Unit (QU) failed to provide adequate oversight. Investigators observed employees moving off-site trash bags containing shredded and torn documents, and production staff signing documents non-contemporaneously, with the firm's camera location procedure being incorrect and approved by QU personnel shortly before the inspection.

The FDA requires a comprehensive, independent assessment and remediation plan for laboratory