FDA 483 - Athenex Pharma Solutions, LLC - August 28, 2019

This FDA Form 483 was issued to Athenex Pharma Solutions, LLC, an outsourcing facility located at 11342 Main St, Clarence, NY 14031-1718. The inspection was conducted from August 19, 2019, to August 28, 2019. Robert Keem, General Manager, was the individual to whom the report was issued.

The inspection revealed one observation: Written production and process control procedures were not followed in the execution of production and process control functions.

Specifically: A. On August 20, 2019, during the manufacturing of Norepinephrine 1mg/ml, Lot# S1900185, an operator did not wipe down all work surfaces and equipment with a clean room wipe thoroughly wetted with (b)(4), contrary to SOP No. APS-SOP-0344 "503B Bulk Formulation-(b)(4) and Sealing Process." B. On August 23, 2019, during the manufacturing of Neostigmine Methylsulfate 5mg/5ml syringe, Lot# F1900899, an operator was observed wiping the bottom of the container (b)(4) with the (b)(4) cloth during drug production in the ISO 5 classified area, which deviates from SOP No. APS