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# 1 Observation on Athenex Pharma FDA-483
- URL: https://www.fdaweb.com/1-observation-on-athenex-pharma-fda-483/
- Published: 2022-11-15T12:00:00.000Z
- Updated: 2026-09-14T18:06:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153202

FDA has released the form FDA-483 issued following a 9/8-9/16 inspection at Athenex Pharma Solutions, a Clarence, NY, outsourcing facility. The one inspection observation [listed](https://www.fda.gov/media/163093/download?ref=fdaweb.com) was the failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed.