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

An FDA inspection of Athenex Pharma Solutions, LLC, an outsourcing facility located at 11342 Main St, Clarence, NY, was conducted from December 5-13, 2017. The inspection, led by Investigator Rachael A. Moliver, identified four observations.

Observation 1 noted deficiencies in aseptic processing area cleaning and disinfection. An operator was observed on December 6, 2017, using an incorrect disinfectant and improper technique for an ISO 5 Horizontal Laminar Flow Hood, deviating from the firm's procedure and smoke studies.

Observation 2 cited deficiencies in environmental monitoring. On December 6, 2017, no environmental monitoring sampling was performed in the ISO 5 area of a Horizontal Laminar Flow Hood where an operator was working, despite the firm's media fill validations and environmental monitoring procedure.

Observation 3 addressed inadequate temperature control for drug product storage. Approved human finished drug products (active ingredients) were stored in an unmonitored area of the warehouse, separate from the firm's monitored temperature probes. The firm had only conducted a Spring temperature mapping study, which showed a broader temperature range in the raw material storage location than where probes were placed, and had not performed studies under worst-case Summer and Winter conditions.

Observation 4 identified deficiencies in drug product labeling. Labels for several drug products, including Epinephrine, Phenylephrine, and Norepinephrine formulations, lacked required information