FDA 483 - Zoetis Belgium S.A. - March 25, 2022

Zoetis Belgium S.A., an API manufacturer in Rathdrum, Ireland, was cited for significant deficiencies in its quality systems. Observations included inadequate deviation management, incomplete master batch records lacking critical verification steps, and an insufficient equipment calibration program. Additionally, the firm failed to ensure compliance with its training program, with many employee training deficiencies remaining unresolved.