FDA 483 - O3UV, LLC - August 31, 2023

O3UV, LLC in Grand Ledge, MI, a medical device establishment, was cited for numerous deficiencies in its quality management system. The inspection revealed a pervasive lack of documented and implemented procedures across critical areas, including corrective and preventive actions, design controls, complaint handling, purchasing, acceptance activities, process controls, device history records, quality audits, and management review. These findings indicate significant non-compliance with regulatory requirements for medical device manufacturing.