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Zoetis Manufacturing Italia S.R.L. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Zoetis Manufacturing Italia S.R.L. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Zoetis Manufacturing Italia S.R.L." is on file.

What these totals cover: FDA records filed under the name "Zoetis Manufacturing Italia S.R.L." and its spelling variant "Zoetis Manufacturing Italia".

Latest inspection: Apr 4, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	3	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Zoetis Manufacturing Italia S.R.L.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

3 inspections from Apr 30, 2015 to Apr 4, 2025.

Date	Site	Product	Classification	FEI
Apr 4, 2025	Catania, Italy	Veterinary	Voluntary Action Indicated (VAI)	3010097713
Jan 19, 2018	Catania, Italy	Veterinary	No Action Indicated (NAI)	3010097713
Apr 30, 2015	Catania, Italy	Drugs	Voluntary Action Indicated (VAI)	3010097713

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3010097713	Catania, Italy	3	Apr 4, 2025

Zoetis Manufacturing Italia S.R.L. and the FDA: common questions

Has Zoetis Manufacturing Italia S.R.L. received an FDA warning letter?

No FDA warning letter addressed to the name "Zoetis Manufacturing Italia S.R.L." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Zoetis Manufacturing Italia S.R.L. received an FDA Form 483?

FDA has not published a Form 483 for "Zoetis Manufacturing Italia S.R.L." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Zoetis Manufacturing Italia S.R.L.?

The most recent FDA inspection on file ended Apr 4, 2025 at Catania, Italy and was classified VAI. FDA has 3 inspections of Zoetis Manufacturing Italia S.R.L. on file.

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