483
National Advanced Endoscopy Devices IncFDA 483 - National Advanced Endoscopy Devices Inc - August 30, 2019
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Record Details
An FDA inspection of National Advanced Endoscopy Devices Inc in Canoga Park, CA, identified a significant issue with design control documentation. The firm failed to properly document design review results in their design history files for medical devices such as laparoscopes and arthroscopes. This indicates a lapse in adherence to quality system requirements for medical device manufacturing.
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ID · bfdb3882-9673-49dc-815d-3531794d92a1