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

Source: https://www.keypedia.com/records/483/national-advanced-endoscopy-devices-inc/8583bf8d-fd0c-4642-8101-e45b45d2369f

> FDA 483 for National Advanced Endoscopy Devices Inc on September 03, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: National Advanced Endoscopy Devices Inc
- Inspection Date: 2020-09-03
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Documents

- [483 - 2019-08-30](https://www.keypedia.com/records/483/national-advanced-endoscopy-devices-inc/bfdb3882-9673-49dc-815d-3531794d92a1)

## Related Officers

- [investigator](https://www.keypedia.com/people/juanita-banuelos/b8b581ef-b9f3-4d77-a9fa-691223dbb7f4)

Company: https://www.keypedia.com/companies/national-advanced-endoscopy-devices-inc/06acc5d3-a599-4eab-8af9-7f21f65bb4ea

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6