FDA EIR - Zoetis Belgium SA - September 28, 2021

An FDA pre-approval inspection was conducted at Zoetis Belgium SA in Tullamore, County Offaly, Ireland, from September 20 to September 28, 2021. The inspection's primary objective was to assess the facility's readiness and adherence to Current Good Manufacturing Practices (cGMP) for its new animal drug application (NADA N-141546-A-0000) concerning frunevetmab, an anti-nerve growth factor monoclonal antibody drug substance for veterinary use. The regulatory framework for this assessment included requirements under 21 CFR Parts 210 and 211, 21 CFR Part 314, and the Federal Food, Drug and Cosmetic Act, specifically guided by the Pre-Approval Inspection for New Animal Drug Application (CPGM 7368.001). The inspection comprehensively reviewed various operational aspects, including quality unit responsibilities, process deviations, out-of-specification investigations, personnel training and qualifications, equipment maintenance, facility controls, laboratory operations, production records, supplier qualifications, and stability data. Emphasis was placed on controls associated with critical manufacturing processes and the integrity of related documentation. Notably, the inspection concluded without disclosing any significant cGMP deficiencies, resulting in no issuance of an FDA Form 483 (Inspectional Observations). As a post-inspection commitment, Zoetis Belgium SA agreed to perform specific analytical tests on each batch of frunevetmab drug substance.