# FDA 483 - University of Utah Cell Therapy and Regenerative Medicine - July 13, 2018

Source: https://www.keypedia.com/records/483/university-of-utah-cell-therapy-and-regenerative-medicine/024bfb8a-7cf4-4dd7-a0e9-00254b7159e7

> FDA 483 for University of Utah Cell Therapy and Regenerative Medicine on July 13, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Utah Cell Therapy and Regenerative Medicine
- Inspection Date: 2018-07-13
- Product Type: biologics
- Office Name: Denver District Office
- Summary: An FDA inspection of the University of Utah Cell Therapy Facility in Salt Lake City, UT, identified a significant deficiency in the quality control unit's authority. Specifically, the Quality Supervisor was found to have reviewed and released batch records without adequate access to production activities or knowledge of process controls and specifications. This indicates a breakdown in the firm's quality oversight for its biological drug and HCT/P products.

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## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Travis S. Bradley](https://www.keypedia.com/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)
- [Manager, Data Science and Engineering](https://www.keypedia.com/people/kelly-d-moore/a5778f12-e968-4fc9-8391-b2cb5753232a)

Company: https://www.keypedia.com/companies/university-of-utah-cell-therapy-and-regenerative-medicine/ff81522d-fc36-4ade-b344-1696f6f212ab

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face