FDA 483 - University of Utah Cell Therapy and Regenerative Medicine - September 23, 2024

An FDA inspection of University of Utah Cell Therapy and Regenerative Medicine, a tissue processor, was conducted from September 23 to September 30, 2024. The inspection resulted in two key observations under the Federal Food, Drug and Cosmetic Act, highlighting deficiencies in record-keeping and product tracking. The first observation noted that critical records were not maintained concurrently with processing steps. Specifically, documentation for the shipment of amniotic membrane products to, and receipt from, a contract sterilizer was not recorded in a timely manner. Examples showed significant delays, with some batch records updated months after the event or entirely missing details for certain batches, compromising traceability. The second observation identified failures in the firm's system for tracking the disposition of Human Cell, Tissue, or Cellular and Tissue-Based Products (HCT/Ps). The firm's batch records and an Excel spreadsheet contained inaccurate information regarding the physical storage locations of processed amniotic membrane products. An instance was cited where a labeled quarantine bin, documented as holding product, was found to be empty during the inspection. These findings indicate a requirement for the firm to implement corrective actions to enhance its record-keeping practices and strengthen its product tracking systems, ensuring comprehensive control over its tissue processing operations and adherence to regulatory standards.