# FDA 483 - Cook Biotech, Inc. - July 01, 2019

Source: https://www.keypedia.com/records/483/cook-biotech-inc/e2eaaa79-38c0-42b1-be3f-46c7d7146774

> FDA 483 for Cook Biotech, Inc. on July 01, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cook Biotech, Inc.
- Inspection Date: 2019-07-01
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Cook Biotech Incorporated in W Lafayette, IN, was cited for two significant issues during an FDA inspection. The firm failed to adequately investigate deviations related to environmental and personnel monitoring, documenting causes as "Unknown" without further inquiry. Additionally, batch records were not maintained concurrently with processing steps, showing incorrect or identical completion dates for different activities.

## Related Officers

- [Travis S. Bradley](https://www.keypedia.com/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

Company: https://www.keypedia.com/companies/cook-biotech-inc/762feaad-3ba4-431a-9503-d031707ac440

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0