FDA 483 - Zoetis LLC - May 23, 2022

An FDA inspection of Zoetis LLC in Lincoln, NE, an animal drug manufacturer, revealed significant deficiencies in quality control and laboratory practices. The firm failed to thoroughly investigate numerous complaints, including those involving adverse events and animal deaths, and lacked scientific justification for critical laboratory test methods. These issues indicate a serious breakdown in the firm's quality system and control over its pharmaceutical products.