# FDA 483 - University of Utah Cell Therapy and Regenerative Medicine - September 30, 2024

Source: https://www.keypedia.com/records/483/university-of-utah-cell-therapy-and-regenerative-medicine/51c52660-3d6e-4304-a8ef-adcd244d09a6

> FDA 483 for University of Utah Cell Therapy and Regenerative Medicine on September 30, 2024. Product: other. 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: 2024-09-30
- Product Type: other
- Office Name: Denver District Office
- Summary: The FDA issued a Form 483 to University of Utah Cell Therapy and Regenerative Medicine in Salt Lake City, UT, citing two observations related to inadequate record-keeping and tracking of amniotic membrane products. The firm failed to concurrently document shipping and receipt information for products sent to and from a contract sterilizer, and its tracking system did not accurately reflect the physical location of processed HCT/Ps. These issues indicate deficiencies in maintaining control over product records and inventory.

## Related Documents

- [483 - 2018-07-13](https://www.keypedia.com/records/483/university-of-utah-cell-therapy-and-regenerative-medicine/024bfb8a-7cf4-4dd7-a0e9-00254b7159e7)

## Related Officers

- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

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