# FDA 483 - Smithfield Bioscience Inc - May 15, 2019

Source: https://www.keypedia.com/records/483/smithfield-bioscience-inc/42c41f9d-137a-4525-a326-4548b89e4eea

> FDA 483 for Smithfield Bioscience Inc on May 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Smithfield Bioscience Inc
- Inspection Date: 2019-05-15
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Smithfield Bioscience Inc in Cincinnati, OH, an API manufacturer, revealed a significant failure to conduct investigations into out-of-specification (OOS) results. The firm repeatedly re-analyzed heparin sodium samples and re-cleaned environmental monitoring areas without proper investigation or management approval. These findings indicate serious deficiencies in the firm's quality control and investigation processes.

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- [483 - 2016-10-27](https://www.keypedia.com/records/483/smithfield-bioscience-inc/526e561f-ce17-421d-9327-52d8c6ce2b8a)
- [483 - 2022-07-15](https://www.keypedia.com/records/483/smithfield-bioscience-inc/3789f259-60b8-43fe-bd5b-6e377ac56d90)
- [483 - 2025-12-23](https://www.keypedia.com/records/483/smithfield-bioscience-inc/23bc4453-7c80-42e1-9453-30614e74e460)

## Related Officers

- [Drug Specialist](https://www.keypedia.com/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)
- [Jon P. Antoniou](https://www.keypedia.com/people/jon-p-antoniou/e42f4f7d-dbdb-4d85-a755-92cb29c249bc)

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