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

Source: https://www.keypedia.com/records/483/smithfield-bioscience-inc/a07bffb9-1df4-41c2-824a-9e2d4c05871c

> 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: Food and Drug Administration
- Summary: An FDA Form 483 was issued on July 15, 2022, following an inspection that revealed significant deficiencies in quality control and manufacturing practices. While the firm name is not provided in this excerpt, the document details critical observations, primarily concerning Heparin Sodium, USP finished Active Pharmaceutical Ingredient (API). A repeat observation cited the failure to conduct thorough investigations into unexplained discrepancies and out-of-specification (OOS) results. Specifically, 12 out of 19 OOS laboratory investigations for Heparin Sodium API were invalidated without comprehensive manufacturing reviews, confirmatory testing, or scientifically sound conclusions. Similarly, environmental excursion investigations were invalidated without proper scientific justification, even after discovering microbial contamination like Bacillus cereus in a processing room, leading to delayed cleaning and continued production without verifying bioburden reduction. The firm also failed to thoroughly investigate a customer complaint regarding an OOS lot.

Environmental monitoring was deemed unrepresentative, with most samples collected post-cleaning rather than during active production, and lacking scientific justification for limited sampling locations. Furthermore, contract testing laboratories performing GMP testing for Heparin Sodium, including identity and elemental impurity analysis, were not fully qualified. This included a failure to perform initial audits for some labs and a lack of written GMP responsibilities for others. The firm is required to address these observations by implementing robust corrective and preventive actions to ensure compliance with Good Manufacturing Practices.

## 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)
- [EIR - 2022-07-15](https://www.keypedia.com/records/eir/smithfield-bioscience-inc/e001133f-6d66-4edc-a8fc-ea64a9fb1d59)
- [483 - 2025-12-23](https://www.keypedia.com/records/483/smithfield-bioscience-inc/23bc4453-7c80-42e1-9453-30614e74e460)

## Related Officers

- [Director](https://www.keypedia.com/people/joann-m/0a459cd4-7849-4687-8811-4868144e3be3)
- [Drug Specialist](https://www.keypedia.com/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)
- [Amanda M Dunneback, Investigator](https://www.keypedia.com/people/amanda-m-dunneback-investigator/8bb2464a-b1a2-4cff-82e2-6e5fb6583028)

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

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516