# FDA 483 - Smithfield Bioscience Inc - July 15, 2022

Source: https://www.keypedia.com/records/483/smithfield-bioscience-inc/3789f259-60b8-43fe-bd5b-6e377ac56d90

> FDA 483 for Smithfield Bioscience Inc on July 15, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Smithfield Bioscience Inc
- Inspection Date: 2022-07-15
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Smithfield Bioscience Inc. in Cincinnati, OH, received a Form 483 with three observations related to its manufacturing of Heparin Sodium, USP finished API. The inspection revealed significant issues with inadequate investigations into out-of-specification results and environmental excursions, a repeat observation from a previous inspection. Additionally, the firm's environmental monitoring program was found to be unrepresentative of production conditions, and contract testing laboratories were not properly qualified.

## 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 - 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)
- [investigator](https://www.keypedia.com/people/amanda-m-dunneback/ee8334d4-88ab-4c52-b34b-1286a0066609)

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