# FDA 483 - Avion Pharmaceuticals, LLC - November 08, 2023

Source: https://www.keypedia.com/records/483/avion-pharmaceuticals-llc/0bf8f422-2ac8-41e1-b815-f2cf732782c8

> FDA 483 for Avion Pharmaceuticals, LLC on November 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avion Pharmaceuticals, LLC
- Inspection Date: 2023-11-08
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Avion Pharmaceuticals, LLC in Alpharetta, GA, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in process validation for drug products, inadequate quality control unit procedures including review of CMO records and supplier qualification, and failures in thoroughly reviewing discrepancies and investigations. Additionally, the firm lacked established procedures for handling returned drug products.

## Related Officers

- [Susan O. Oladeji](https://www.keypedia.com/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)

Company: https://www.keypedia.com/companies/avion-pharmaceuticals-llc/c909aea3-b381-4105-86ee-9f7260b10a06

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