FDA WARNING_LETTER - Somerset Therapeutics Limited - February 21, 2025

Somerset Therapeutics Private Limited, located in Bengaluru, India, was inspected by the FDA from February 10 to 21, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, as outlined in Title 21 CFR parts 210 and 211. These violations led to the classification of their drug products as adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key issues identified include inadequate investigation of discrepancies and failures in product batches, particularly concerning contamination in a media fill failure and out-of-specification results related to impurities in drug products. The firm also failed to maintain proper environmental monitoring and equipment maintenance, compromising aseptic conditions. Notably, tape was used inappropriately in a critical aseptic area, raising concerns about facility oversight.

Somerset Therapeutics did not submit required Field Alert Reports (FAR) to the FDA, violating section 505(k) of the FD&C Act. The company"s response to the FDA"s Form 483 was deemed inadequate, as it failed to address the root causes of contamination and ensure effective corrective and preventive actions (CAPA).

The FDA requires Somerset Therapeutics to provide a comprehensive plan addressing these issues, including a systemic review of their environmental monitoring program, improved lifecycle oversight of suppliers, and assurance of data integrity in environmental monitoring. The firm must also establish an adequate system for maintaining equipment to control aseptic conditions. Failure to address these violations may result in further regulatory actions.