FDA 483 - Zoetis Belgium S.A. - November 22, 2022

Zoetis Belgium S.A., a sterile drug products manufacturer in Louvain-la-Neuve, Belgium, was cited for significant deficiencies in its quality control and manufacturing processes. The inspection revealed failures in preventing microbiological contamination, adhering to stability testing programs, thoroughly investigating customer complaints, and establishing adequate production controls for visual particulate inspection. These issues indicate a lack of robust quality assurance for sterile drug products.