FDA WARNING_LETTER - Seema International - May 21, 2025

The FDA issued a warning letter to Seema International following an inspection of its New Delhi, India facility conducted from May 15 to 21, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) standards for active pharmaceutical ingredients (APIs), leading the FDA to classify the company’s products as adulterated under the Federal Food, Drug, and Cosmetic Act. Primary concerns included the failure to adequately clean and maintain manufacturing equipment to prevent cross-contamination, which was noted as a repeat violation. Additionally, the firm lacked a documented stability testing program to justify product expiration dates and failed to ensure its Quality Unit provided necessary oversight. Specifically, the Quality Unit neglected to review batch records, perform required identity testing on bulk materials, and maintain proper supplier qualification or product traceability. Due to these persistent issues, the FDA placed the company’s products on an Import Alert in September 2025. To address these deficiencies, Seema International is required to submit a comprehensive corrective and preventive action (CAPA) plan, conduct a retrospective risk assessment of its products, and implement a robust stability monitoring program. The FDA also strongly recommended that the firm hire a qualified consultant to perform a full six-system audit of their operations. A detailed written response is required within 15 working days to outline the steps taken to ensure future compliance.