# FDA 483 - Somerset Therapeutics Limited - April 04, 2022

Source: https://www.keypedia.com/records/483/somerset-therapeutics-limited/3c1a3c41-aae5-4b8e-a8df-e622f065b3b6

> FDA 483 for Somerset Therapeutics Limited on April 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Somerset Therapeutics Limited
- Inspection Date: 2022-04-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Somerset Therapeutics Limited in Bangalore, India, revealed significant deficiencies in their sterile drug manufacturing processes. The firm failed to adhere to procedures preventing microbiological contamination, exhibited a deficient environmental monitoring program, and conducted inadequate investigations into product discrepancies and out-of-specification results. These findings, including repeat observations, indicate serious concerns regarding the quality control unit's oversight and aseptic processing practices.

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## Related Officers

- [Kellia A. Hicks](https://www.keypedia.com/people/kellia-a-hicks/54270562-7e91-44c2-ac5c-b340623f439c)
- [Ileana Barreto-Petit](https://www.keypedia.com/people/ileana-barreto-petit/e5c865ac-14a2-47d4-954b-464a865e8684)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1