FDA 483 - Christopher C. Canale, M.D. - August 02, 2019

An FDA inspection of Wasatch Access Research LLC in Salt Lake City, UT, revealed significant deficiencies in the conduct of clinical investigations and the maintenance of adequate case histories. The firm failed to ensure investigations adhered to the investigational plan, with instances of falsified source documents by staff that went undetected by the Principal Investigator for an extended period. Additionally, critical original source documents for a study subject were missing and unrecoverable, indicating serious issues with data integrity and oversight of clinical trials.