FDA 483 - Eurovet Animal Health B.V. - October 25, 2022

Eurovet Animal Health B.V. in Bladel, Netherlands, an animal drug manufacturer, was inspected by the FDA from October 17-25, 2022. The inspection revealed significant deficiencies in aseptic processing, environmental control, quality unit oversight, and data integrity, indicating a lack of adequate procedures and controls to prevent microbiological contamination and ensure product quality. These issues pose a high risk to the sterility and quality of their animal drug products.