Priority Environmental Solutions Inc – FDA 483, May 11, 2022

Priority Environmental Solutions Inc, a medical device manufacturer in Hartland, WI, was inspected by the FDA, revealing significant deficiencies in its quality system. The firm failed to adequately maintain device master and history records, establish proper acceptance activities, and implement effective document and purchasing controls. These issues indicate a lack of robust procedures and documentation necessary to ensure the quality and compliance of their medical devices.