FDA 483 - Ward Photonics, LLC - January 19, 2023

Ward Photonics, LLC, a medical device manufacturer in Cocoa Beach, FL, was inspected regarding its LED light therapy systems. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for complaint handling, corrective and preventive actions, and medical device reporting. Several observations were repeats, indicating persistent issues with the firm's quality management system.