# FDA 483 - Somerset Therapeutics Limited - February 19, 2020

Source: https://www.keypedia.com/records/483/somerset-therapeutics-limited/3aef1f14-a625-4846-b987-f3e996b7bed6

> FDA 483 for Somerset Therapeutics Limited on February 19, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Somerset Therapeutics Limited
- Inspection Date: 2020-02-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Wintac Limited, a sterile drug manufacturer in Bangalore, India, was inspected by the FDA from February 10-19, 2020. The inspection revealed significant deficiencies in aseptic processing validation, microbiological contamination prevention, quality control unit procedures, and laboratory controls. Issues included inadequate media fill studies, lack of continuous environmental monitoring, problems with container/closure leachables, and insufficient investigation and CAPA implementation.

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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