FDA 483 - Microlight Corporation of America - January 24, 2025

Microlight Corporation of America, a specification developer of the MicroLight SmartLaser, was cited with 13 observations during an FDA inspection. The firm demonstrated significant deficiencies across its quality system, particularly in design control, device master records, complaint handling, and radiation safety. Many issues indicate a systemic lack of established or adequately maintained procedures and documentation, with some being repeat observations from a previous inspection.