# FDA 483 - Avioq, Inc. - February 27, 2019

Source: https://www.globalkeysolutions.net/records/483/avioq-inc/9998fb60-44bb-4343-9957-605361f99120

> FDA 483 for Avioq, Inc. on February 27, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avioq, Inc.
- Inspection Date: 2019-02-27
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Avioq, Inc., an in-vitro diagnostic manufacturer in Research Triangle Park, Durham, NC, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately investigate and conclude numerous product complaints, implement changes with proper validation, and adhere to or maintain complete standard operating procedures and quality agreements. Additionally, the inspection revealed issues with the qualification and verification of incoming materials.

## Related Documents

- [483 - 2023-12-05](https://www.globalkeysolutions.net/records/483/avioq-inc/c2813b4f-ab4b-4dc6-a81f-447e7d97386b)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/jacqueline-m-diaz-albertini/9ff937fe-4e9b-445a-80fa-e26800d923b8)

Company: https://www.globalkeysolutions.net/companies/avioq-inc/7bf5243a-9d4e-4335-bd22-7d4075729928

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7