FDA 483 - USA Medical, LLC - March 15, 2022

An FDA inspection of USA Medical, LLC in Grapevine, TX, a medical device manufacturer, from February 28 to March 15, 2022, revealed severe and pervasive deficiencies across its quality system. The firm failed to establish fundamental procedures for nearly all aspects of medical device manufacturing and distribution, particularly concerning SARS-CoV-2 Antigen Rapid Test kits. This indicates a complete lack of a functional quality system, posing significant risks to product quality and patient safety.