483
Microlight Corporation of AmericaMicrolight Corporation of America – FDA 483, Jul 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.
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- Dallas District Office
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ID · 9d3e3827-7be1-494b-9423-ff13ae1de46a
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