FDA Issues Warning Letter to Cdymax India Pharma Over OOS and CAPA Failures

On 13 November 2025, the U.S. FDA issued a Warning Letter following an April 2025 inspection of Cdymax India Pharma Private Limited’s API manufacturing site in Bangalore. The agency identified systemic failures in handling Out-of-Specification (OOS) results, laboratory investigations, and the Corrective and Preventive Action (CAPA) system.

Key Findings:

• Laboratory Incidents: Since 2023, ~1,500 laboratory incidents—including OOS results and major analytical events—were recorded. Investigations were often scientifically inadequate, lacking root cause analysis, with ineffective or inconsistent CAPAs, and absent manufacturing investigations.
• Critical Example: Repeated OOS results from an “unknown peak” in stability samples were invalidated after a passing retest. FDA noted the contaminant was never identified, no manufacturing investigation occurred, and the CAPA (“refresher training”) was not scientifically justified.
• Regulatory Expectation: Suspected lab errors alone cannot close an OOS investigation; a full manufacturing investigation is required if the lab root cause is inconclusive.
• Method Validation: Several analytical methods were inadequately validated, with deficiencies in precision, robustness, and system suitability.

The FDA requests a system-wide reassessment of OOS and deviation handling and a retrospective review of all OOS cases over the past four years, including released U.S. batches.

Full Warning Letter: FDA website.

18-12-2025