# FDA 483 - Avioq, Inc. - December 05, 2023

Source: https://www.globalkeysolutions.net/records/483/avioq-inc/c2813b4f-ab4b-4dc6-a81f-447e7d97386b

> FDA 483 for Avioq, Inc. on December 05, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avioq, Inc.
- Inspection Date: 2023-12-05
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Avioq, Inc. in Durham, NC, an In Vitro Device Diagnostic Manufacturer, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to maintain adequate device history records for antigen aliquots used in IVD test kits. Additionally, observations noted a lack of established procedures for product identification during production and for controlling storage areas, leading to improper segregation of materials.

## Related Documents

- [483 - 2019-02-27](https://www.globalkeysolutions.net/records/483/avioq-inc/9998fb60-44bb-4343-9957-605361f99120)

## Related Officers

- [FDA_PERSONNEL](https://www.globalkeysolutions.net/people/edward-a-brunt/f823f6cb-7fb1-422b-b022-cb0d673f6210)
- [Gene D. Arcy](https://www.globalkeysolutions.net/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)
- [investigator](https://www.globalkeysolutions.net/people/priscilla-m-pastrana/170080d1-49da-42d7-8615-c774cac9f7ec)

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