FDA 483 - Zoetis Manufacturing Italia s.r.l. - April 04, 2025

Zoetis Manufacturing Italia Srl in Catania, Italy, was inspected from March 31 to April 4, 2025, revealing significant deficiencies in its Quality Unit. The firm failed to thoroughly investigate laboratory out-of-specification results and customer complaints. Additionally, the Quality Unit did not adequately review and address deficiencies in analytical method validations.