FDA 483 - North American Diagnostics - June 23, 2022

An FDA inspection of North American Diagnostics in Holly Hill, FL, revealed numerous significant quality system deficiencies related to their ORAL RAPID ™ SARS-CoV-2 Antigen Rapid Test Kit. The firm lacked established procedures for design control, production processes, process validation, acceptance activities, corrective and preventive actions, device distribution, complaint handling, and medical device reporting. Furthermore, the firm distributed its COVID-19 test kit without the required Emergency Use Authorization.