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# Athenex Pharma Solutions FDA-483
- URL: https://www.fdaweb.com/athenex-pharma-solutions-fda-483/
- Published: 2020-01-28T12:00:00.000Z
- Updated: 2026-09-14T16:00:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145941

FDA has just released the FDA-483 issued following a 12/5-12/13/17 inspection at Athenex Pharma Solutions, a Clarence, NY, outsourcing facility. Inspection observations were: 

- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- equipment for adequate control over temperature is not provided when appropriate for the manufacture, processing, packing, or holding of a drug product; and
- the labels of the facility’s drug products are deficient.