FDA 483 - Navigate Biopharma Services Inc - March 01, 2019

An FDA inspection of Navigate Biopharma Services Inc in Carlsbad, CA, a medical device sponsor, revealed significant deficiencies in their clinical trial practices. The firm failed to ensure complete informed consent records, with instances of unverified or improperly dated consent forms prior to sample collection. Additionally, the inspection found that IRB review and approval were not secured for an investigational study protocol before patient samples were processed.