FDA EIR - Athenex Pharma Solutions, LLC - March 12, 2020

An FDA pre-approval inspection was conducted at Athenex Pharma Solutions, LLC in Clarence, NY, from March 11-12, 2020. The inspection focused on the company's manufacturing operations for New Drug Application (NDA) 213189, Tirbanibulin ointment, 1%, a non-sterile commercial drug product, under the Compliance Program Guidance Manual 7346.832. While no FDA Form 483 for objectionable conditions was issued, verbal observations were discussed with management. These included concerns about document control, deficiencies in documentation practices—specifically the lack of clear mechanisms to identify original issuance or controlled usage of release testing results and ambiguous identification of personnel performing calculations. Additionally, the adequacy of reviewing investigations from third-party laboratories was highlighted, noting the approval of an Out-of-Specification result closure without full data verification or confirmed root cause. The company's operations are subject to Current Good Manufacturing Practices (21 CFR Parts 210/211) and pre-market approval requirements (21 CFR Part 314). Management committed to evaluating and implementing voluntary corrective and preventive actions (CAPAs) to address these observations, with the FDA emphasizing that failure to do so could lead to further regulatory actions. The final classification of the inspection remains at the discretion of the FDA's compliance branch.