FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Risk Analysis Missing at Chinese Medical Laser Maker

Nov. 20, 2018

Risk analysis, validation procedures and appropriate test methods were found to be inadequate at China’s Beijing ADSS Development during a Feb. 5 to Feb 8 FDA inspection of the firm’s Beijing facility.

The company makes a number of aesthetic and medical laser products, including lasers for hair removal, face and body contouring, acne scars and other treatments.

Design validation was not performed under defined operating conditions on initial production units, and the company didn’t “adequately ensure the device conforms to user needs,” the FDA Form 483 said.

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