National Advanced Endoscopy Devices IncSeptember 3, 2020

FDA 483 - National Advanced Endoscopy Devices Inc - September 03, 2020

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Record Details

National Advanced Endoscopy Devices Inc, a medical device manufacturer in Canoga Park, CA, was inspected by the FDA. The inspection revealed one observation regarding the inadequate maintenance of device history records. Specifically, documentation for finished device testing, including scope tests for AED Sinuscopes, was missing from several device history records.

Company: National Advanced Endoscopy Devices Inc
Inspection Date: September 3, 2020
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Juanita Banuelos (investigator)

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ID · 8583bf8d-fd0c-4642-8101-e45b45d2369f