# FDA 483 - National Advanced Endoscopy Devices Inc - August 30, 2019

Source: https://www.keypedia.com/records/483/national-advanced-endoscopy-devices-inc/bfdb3882-9673-49dc-815d-3531794d92a1

> FDA 483 for National Advanced Endoscopy Devices Inc on August 30, 2019. 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: 2019-08-30
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Documents

- [483 - 2020-09-03](https://www.keypedia.com/records/483/national-advanced-endoscopy-devices-inc/8583bf8d-fd0c-4642-8101-e45b45d2369f)

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

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