FDA WARNING_LETTER - Intas Pharmaceuticals Limited - September 17, 2025

On March 30, 2026, the FDA issued a warning letter to Intas Pharmaceuticals Limited following an inspection of its manufacturing facility in Dehradun, India, conducted between September 8 and 17, 2025. The document outlines significant failures to comply with Current Good Manufacturing Practice (CGMP) regulations, leading the FDA to classify the firm"s drug products as adulterated under the Federal Food, Drug, and Cosmetic Act. The primary violations include inadequate investigations into out-of-specification results for subpotent tablet batches, which resulted in multiple product recalls and ineffective corrective actions. Additionally, the FDA identified serious data integrity concerns, noting that quality assurance staff instructed software vendors to modify electronic batch records without capturing those changes in audit trails. The company’s quality control unit was also found to have failed in its oversight responsibilities. To rectify these issues, the FDA requires Intas Pharmaceuticals to provide a comprehensive impact assessment for affected products, undergo an independent third-party review of its investigation and corrective action programs, and perform a retrospective audit of all software-related communications and batch record modifications. The company was given 15 working days to respond with a detailed plan for remediation, with the FDA warning that failure to address these deficiencies may lead to the withholding of new product approvals or the refusal of drug shipments into the United States.