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

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.