483
Microlight Corporation of AmericaFDA 483 - Microlight Corporation of America - July 11, 2018
Record Details
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.
- Office
- Dallas District Office
- Person
Open in Dashboard
ID · 9d3e3827-7be1-494b-9423-ff13ae1de46a