# Avioq, Inc. – FDA 483, May 14, 2026

Source: https://www.keypedia.com/records/483/avioq-inc/d57fb3f2-06f4-471f-a3d6-ffb7a5fb5fd0

> FDA 483 for Avioq, Inc. on May 14, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avioq, Inc.
- Inspection Date: 2026-05-14
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: Avioq, Inc. in Durham, NC, received an FDA Form 483 citing inadequate maintenance of records for risk management activities during product realization. The inspection revealed deficiencies in the firm's risk assessments for several non-conformance reports, including issues with incorrect expiration dates, deviations in lysate usage, and the use of non-conforming components. These assessments were found to lack specific data and failed to properly categorize risks according to the firm's own standard operating procedures.

## Related Documents

- [483 - 2023-12-05](https://www.keypedia.com/records/483/avioq-inc/c2813b4f-ab4b-4dc6-a81f-447e7d97386b) — date: December 5, 2023
- [483 - 2019-02-27](https://www.keypedia.com/records/483/avioq-inc/9998fb60-44bb-4343-9957-605361f99120) — date: February 27, 2019

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/david-e-lowe/1a2492c2-4a81-4486-b3af-37f6b7b5216a)
- [Marla A. Cassidy](https://www.keypedia.com/people/marla-a-cassidy/d2859ca5-e77b-4385-9a96-4c785f3ac4c6)

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

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