# FDA 483 - Athenex, Inc. - July 11, 2019

Source: https://www.globalkeysolutions.net/records/483/athenex-inc/98ddd837-830d-41fc-a728-0218a022bb20

> FDA 483 for Athenex, Inc. on July 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Athenex, Inc.
- Inspection Date: 2019-07-11
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Athenex, Inc. in Buffalo, NY, a laboratory/corporate headquarters, was cited for failing to adhere to its own written procedures regarding the timely submission and justification of investigation extension forms. Specifically, several Laboratory Investigation Reports were found to be significantly late without proper extensions. This indicates a breakdown in the firm's quality system for managing deviations and investigations.

## Related Officers

- [Johnna L. Bleem](https://www.globalkeysolutions.net/people/johnna-l-bleem/3fe669bf-e354-4cdc-9337-d5ceb23f1c9f)

Company: https://www.globalkeysolutions.net/companies/athenex-inc/be1cdf97-cc70-481c-b6c3-9f409adcb4d1

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961