# FDA 483 - Smithfield Bioscience Inc - October 27, 2016

Source: https://www.keypedia.com/records/483/smithfield-bioscience-inc/526e561f-ce17-421d-9327-52d8c6ce2b8a

> FDA 483 for Smithfield Bioscience Inc on October 27, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Smithfield Bioscience Inc
- Inspection Date: 2016-10-27
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Celsus Laboratories Inc. in Cincinnati, OH, received a Form 483 citing significant deficiencies in laboratory computer system validation, electronic data oversight, and testing procedures. The inspection also found issues with document control for production batch records, indicating a lack of robust quality unit controls. These observations highlight concerns regarding data integrity and adherence to established manufacturing practices for an API manufacturer.

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## Related Officers

- [Investigator ](https://www.keypedia.com/people/lindsey-schwierjohann/3608e7c0-5bb9-49f0-844d-ddd6f6724fdb)

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