FDA 483 - Zoetis Manufacturing & Research Spain, S.L. - July 28, 2023

An FDA inspection of Zoetis Manufacturing & Research Spain, S.L. in La Vall De Bianya revealed significant deficiencies in the manufacturing of sterile drug products. Observations included inadequate validation of aseptic processes, insufficient control procedures for monitoring manufacturing variability, and incomplete batch production records. These issues raise concerns about the sterility assurance and overall quality control of the drug products.