# FDA 483 - Somerset Therapeutics Limited - February 21, 2025

Source: https://www.keypedia.com/records/483/somerset-therapeutics-limited/bbb74681-03f4-42a9-9628-a52c96fdb0d8

> FDA 483 for Somerset Therapeutics Limited on February 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Somerset Therapeutics Limited
- Inspection Date: 2025-02-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Somerset Therapeutics Private Limited in Bengaluru, India, revealed critical deficiencies in their manufacturing of sterile drug products. The firm failed to submit field alert reports for bacteriological contamination, conducted inadequate investigations into product discrepancies, and exhibited significant lapses in aseptic processing validation and environmental controls. These issues indicate a lack of robust quality systems, potentially compromising the sterility and quality of drug products distributed in the U.S. market.

## Related Documents

- [483 - 2020-02-19](https://www.keypedia.com/records/483/somerset-therapeutics-limited/3aef1f14-a625-4846-b987-f3e996b7bed6)
- [483 - 2022-04-04](https://www.keypedia.com/records/483/somerset-therapeutics-limited/3c1a3c41-aae5-4b8e-a8df-e622f065b3b6)
- [WARNING_LETTER - 2025-02-21](https://www.keypedia.com/records/warning_letter/somerset-therapeutics-limited/2bfc8f0c-6d7b-420a-8e9c-50ec78b72fe9)

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.keypedia.com/companies/somerset-therapeutics-limited/cdfeb30a-e26b-4be1-9ca9-8aaf6434d0a7

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8