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

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.