FDA 483 - Microlight Corporation of America - September 06, 2018

Microlight Corporation of America in Sugar Land, TX, received a Form FDA 483 with six observations during an inspection of its Class 2 (Class IIIb) laser medical devices. The firm failed to maintain a device master record, adequately handle and investigate customer complaints, and establish proper servicing procedures. Additionally, the company lacked records for electronic product radiation safety testing and did not make requested quality system records available for FDA review.