FDA 483 - Protech Leaded Eyewear - December 14, 2018

An FDA inspection of Protech Leaded Eyewear in Lake Park, FL, revealed significant deficiencies across its quality system. The firm failed to establish adequate procedures for Medical Device Reporting, complaint handling, corrective and preventive actions, statistical techniques, supplier evaluation, and document control. These issues indicate a broad lack of compliance with FDA regulations for medical device manufacturing.