Zoetis Manufacturing Italia s.r.l.April 4, 2025

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

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Record Details

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.

Company: Zoetis Manufacturing Italia s.r.l.
Inspection Date: April 4, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Steven A. Brettler (Consumer Safety Officer)

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ID · 8b09faaf-8f8c-4ae2-959a-df33cc66fa37