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Medical Devices / Inspections and Audits

FDA Hits Microlight for Deficient Complaint Handling

Dec. 4, 2018

The FDA flagged Microlight’s Sugar Land, Texas facility for its complaint handling procedures, in a Form 483 after two inspections.

The firm’s documented service complaints — which were categorized as warranty repairs between January 2016 and June 2018 — were actually complaints regarding possible malfunctions of components of the firm’s Class IIIb laser medical devices and were not handled by the company, the agency found.

For example, the facility did not service or repair components involved in complaints relating to its Microlight Class IIIb lasers.

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