Somerset Therapeutics Private Limited

Warning LetterOpen

Mr. Veerappan Subramanian Owner, Chairman, & CEO Somerset Therapeutics Private Limited 300 Franklin Square Drive Somerset , NJ 08873 United StatesFEI 3003821988Issued Sep 4, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3003821988.

Violations5

Issue DateSep 4, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Somerset Therapeutics Private Limited
Location: Mr. Veerappan Subramanian Owner, Chairman, & CEO Somerset Therapeutics Private Limited 300 Franklin Square Drive Somerset , NJ 08873 United States
FEI Number: 3003821988
Country: United States
Issue Date: September 04, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

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.

Somerset Therapeutics Private Limited FDA Warning Letter, September 4, 2025