FDA 483 - Athenex Pharma Solutions, LLC - December 13, 2017

This FDA Form 483 was issued to Athenex Pharma Solutions, LLC, an outsourcing facility located at 11342 Main St, Clarence, NY 14031-1718, following an inspection from December 5 to December 13, 2017. Robert F. Keem, General Manager, was the individual to whom the report was issued.

The inspection revealed four observations:

1. **Deficient Aseptic Processing Area Cleaning/Disinfection:** An operator was observed on December 6, 2017, disinfecting an ISO 5 Laminar Flow Hood with an incorrect disinfectant and in a manner inconsistent with the firm's procedure and smoke studies. The procedure requires disinfection from the cleanest to the dirtiest area, which was not followed.

2. **Deficient Environmental Monitoring:** On December 6, 2017, no environmental monitoring sampling was performed in the ISO 5 area where an operator was working. The firm's media fill validations and environmental monitoring procedure state that viable monitoring should be performed in the ISO 5 area, but it is only performed in the ISO 7 area.

3. **Inadequate Temperature Control for Drug Product Storage:** The firm's temperature-monitored area does not cover all locations where approved human finished drug products (active ingredients) are stored. While temperature probes are in the (b)(4) area of