FDA 483 - Nassr, Ahmad, MD - February 07, 2020

An FDA inspection of Nassr, Ahmad, MD, a clinical investigator site in Rochester, MN, revealed significant deficiencies in the conduct of a clinical study involving investigational devices. Observations included incomplete records for device accountability and receipt, failure to reconsent subjects after protocol amendments, and incomplete source data regarding subject eligibility. These issues indicate a lack of adherence to regulatory requirements for clinical investigations.