Athenex, Inc. – FDA EIR, Sep 17, 2020

An FDA sponsor surveillance inspection of Athenex, Inc., located in Buffalo, NY, was conducted from September 15-17, 2020. This marked the first bioresearch monitoring inspection for Athenex, requested by the Center for Drug Evaluation and Research, Office of Scientific Investigations. The inspection's primary objective was to evaluate Athenex's activities as a sponsor for a clinical trial protocol supporting a New Drug Application. The inspection followed guidance from Compliance Program 7348.810, which focuses on Sponsors, Contract Research Organizations, and Monitors. It encompassed a comprehensive review of Athenex's operating procedures, quality assurance activities, financial disclosures, Institutional Review Board approvals, safety and adverse event reporting, site monitoring reports, data collection processes, and accountability for the investigational product, classified as a drug under the Food, Drug and Cosmetic Act. The clinical study covered involved subjects enrolled at international sites. Significantly, the inspection concluded without any identified violations or issues. A Form FDA 483, Inspectional Observations, was not issued to Athenex, Inc., indicating no regulatory deficiencies were found. No refusals were encountered, and no samples were collected, meaning no corrective or required actions were imposed on the company as a result of this inspection.