FDA WARNING_LETTER - Cdymax (India) Pharma Private Limited - April 25, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Cdymax India Pharma Private Limited following an inspection of its Bangalore, Karnataka, facility from April 21 to 25, 2025. The letter highlights significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs), leading to the APIs being deemed adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The primary violation was the company"s failure to adequately investigate and document out-of-specification (OOS) results and implement appropriate corrective actions. The FDA noted approximately 1,500 laboratory incidents since 2023 involving OOS results and other significant analytical events, many with inadequate root cause analysis and corrective/preventive actions (CAPAs). Investigations frequently failed to classify incidents as OOS results, and manufacturing investigations were often omitted when laboratory root causes were not definitive. An example cited involved an OOS result for an "unknown peak" in a stability sample, where retesting and invalidation occurred without a thorough scientific root cause analysis. The FDA deemed the company"s response inadequate, citing inconsistencies and lack of evidence for systemic remediation. Cdymax India Pharma Private Limited is required to conduct comprehensive, independent assessments of its overall investigation and CAPA programs, including a retrospective review of all laboratory incidents and OOS results for U.S. products over the last four years. These actions must ensure effective root cause analysis, improve quality unit oversight, and implement robust corrective measures to prevent recurrence.