# FDA 483 - Summit Biosciences Inc. - February 21, 2025

Source: https://www.keypedia.com/records/483/summit-biosciences-inc/f1c02c76-4a6d-4a2a-96f8-502730a91773

> FDA 483 for Summit Biosciences Inc. on February 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Summit Biosciences Inc.
- Inspection Date: 2025-02-21
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Summit Biosciences Inc., a drug manufacturer in Lexington, KY, revealed two significant observations. The firm failed to implement adequate systems for Drug Supply Chain Security Act (DSCSA) verification, specifically regarding procedures for identifying and investigating suspect drug products. Additionally, the inspection found a lack of established written procedures for in-process controls, including validated 100% visual inspection and Accepted Quality Limit (AQL) inspection for particulate matter in their nasal drug products.

## Related Officers

- [Ucheabuchi C. Chudi-nwankwor](https://www.keypedia.com/people/ucheabuchi-c-chudi-nwankwor/18b01d08-3cfd-4ace-97b2-5f54b6427661)

Company: https://www.keypedia.com/companies/summit-biosciences-inc/2dadddc5-06ce-43be-914b-1b6e9a76e976

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22