FDA 483 - BioCorRx Inc - August 14, 2020

BioCorRx Inc, a sponsor in Anaheim, CA, was inspected by the FDA from July 28 to August 14, 2020. The inspection revealed significant deficiencies in the conduct and monitoring of an investigational drug study. Findings included failures to provide essential study information to investigators, obtain required investigator statements, and maintain adequate records for investigational drug disposition.