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Somerset Therapeutics Private Limited, a drug manufacturer in India, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered their finished pharmaceutical products adulterated. The facility failed to conduct adequate investigations into batch failures and contamination issues, including a September 2024 media fill failure, and did not properly document deviations or expand investigations to affected products as required. Additionally, the company failed to submit required Field Alert Reports (FARs) to the FDA as mandated by federal regulations. The inspection took place in February 2025 and identified widespread deficiencies in the firm's manufacturing methods, facilities, and controls.