FDA 483 - University of Utah Cell Therapy and Regenerative Medicine - September 30, 2024
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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.
- Inspection Date
- September 30, 2024
- Product Type
- Other
- Office
- Denver District Office
- Person
ID · 51c52660-3d6e-4304-a8ef-adcd244d09a6