FDA 483 - Best Image Optical, Inc. - March 09, 2023

Best Image Optical, Inc. in Doral, FL, a specification developer, was inspected by the FDA. The inspection revealed significant deficiencies across its quality system, with a complete lack of established procedures for critical areas such as Medical Device Reporting, complaint handling, corrective and preventive actions, and quality audits. These findings indicate a fundamental failure to implement essential regulatory requirements for medical device manufacturers.