FDA 483 - Microlight Corporation of America - July 11, 2018

Microlight Corporation of America in Sugar Land, TX, was cited for significant quality system deficiencies related to its Class IIb/IIIb laser medical devices. The firm failed to maintain device master records, adequately investigate device complaints, establish proper servicing procedures, and provide requested records to the FDA. Additionally, there was a lack of electronic product radiation control test records for components.