# FDA 483 - University of Kentucky - November 21, 2019

Source: https://www.keypedia.com/records/483/university-of-kentucky/58fac186-bc7a-46c1-8578-897c4ce30b43

> FDA 483 for University of Kentucky on November 21, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Kentucky
- Inspection Date: 2019-11-21
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: The University of Kentucky's non-clinical laboratory received a Form FDA 483 citing multiple significant deviations from Good Laboratory Practice (GLP) regulations. Observations included failures in data retention, archiving, protocol adherence, quality assurance documentation, and personnel qualifications. These issues indicate a systemic lack of control over critical aspects of nonclinical studies.

## Related Officers

- [investigator](https://www.keypedia.com/people/karen-m-cooper/4813e60d-c8da-4df2-bc48-ecfb06a55cf8)

Company: https://www.keypedia.com/companies/university-of-kentucky/b4f1496c-5e3d-4b88-8817-9a19b37541fe

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22