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

Source: https://www.keypedia.com/records/483/somerset-therapeutics-limited/34341267-fa3e-4bed-b7e8-129978359487

> 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: Baltimore District Office
- Summary: Between February 10 and February 21, 2025, the FDA conducted an inspection of Somerset Therapeutics Private Limited’s sterile drug manufacturing facility in Bengaluru, India. The inspection resulted in a Form 483 identifying ten major areas of concern regarding the facility"s adherence to Current Good Manufacturing Practice (cGMP) standards. A critical violation involved the company’s failure to notify the FDA within the required three-day window after discovering bacterial contamination during a simulated production run. Despite this failure, several batches of injectable products manufactured on the same equipment remain on the U.S. market. Investigators also observed poor hygienic practices, such as operators failing to sanitize hands before touching sterile components and obstructing the sterile airflow required to protect the products. Additionally, physical maintenance issues were noted, including loose tape hanging from the ceiling directly above open drug vials. Further deficiencies were found in the laboratory and quality control departments. The firm failed to thoroughly investigate chemical impurities and lacked scientifically sound procedures for testing drug components. Environmental monitoring was deemed unreliable, and batch records were often incomplete, with various alarms and aborted air samples going unreviewed. To resolve these issues, Somerset Therapeutics must submit a formal response to the FDA detailing their corrective actions. This must include a comprehensive plan to address the root causes of contamination and a rigorous risk assessment for all products currently in distribution.

## 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)
- [483 - 2025-02-21](https://www.keypedia.com/records/483/somerset-therapeutics-limited/bbb74681-03f4-42a9-9628-a52c96fdb0d8)
- [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/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa