FDA 483 - Protech Leaded Eyewear - March 10, 2025

Protech Leaded Eyewear in Lake Park, FL, was inspected from March 4-10, 2025, and received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding the establishment of design control procedures, quality audit procedures, and the adequate maintenance of complaint files, with the latter being a repeat observation.