# FDA 483 - Smithfield Bioscience Inc - December 23, 2025

Source: https://www.keypedia.com/records/483/smithfield-bioscience-inc/23bc4453-7c80-42e1-9453-30614e74e460

> FDA 483 for Smithfield Bioscience Inc on December 23, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Smithfield Bioscience Inc
- Inspection Date: 2025-12-23
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Smithfield Biosciences, Inc. in Cincinnati, OH, an API manufacturer, received a Form 483 with six observations during an inspection from December 16-23, 2025. The inspection revealed significant deficiencies in process validation, supplier qualification, quality unit review of records, investigation of discrepancies, personnel adequacy, and the stability program. These issues indicate a lack of robust quality control and compliance with GMP requirements for API manufacturing.

## Related Documents

- [483 - 2016-10-27](https://www.keypedia.com/records/483/smithfield-bioscience-inc/526e561f-ce17-421d-9327-52d8c6ce2b8a)
- [483 - 2019-05-15](https://www.keypedia.com/records/483/smithfield-bioscience-inc/42c41f9d-137a-4525-a326-4548b89e4eea)
- [483 - 2022-07-15](https://www.keypedia.com/records/483/smithfield-bioscience-inc/3789f259-60b8-43fe-bd5b-6e377ac56d90)

## Related Officers

- [Anna M. Spiros](https://www.keypedia.com/people/anna-m-spiros/13e6a69c-d3d5-431c-9895-0df9b86691b7)
- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)
- [Martin M. Kimani](https://www.keypedia.com/people/martin-m-kimani/fbc296cc-e80e-46f4-a34a-848c8b20da05)

Company: https://www.keypedia.com/companies/smithfield-bioscience-inc/f87613b8-a59a-4a6d-b412-9f2b145f397b

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