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Trifarma S.P.A.

FDA Regulatory Profile

Trifarma S.P.A. has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Trifarma S.P.A." and its spelling variant "Trifarma".

Latest inspection: Sep 27, 2024 · VAI

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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	10	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Trifarma S.P.A.'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	0	0	0	0	0
2024	1	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	1	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	1	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.

Recent FDA inspections

10 inspections from Jan 28, 2010 to Sep 27, 2024.

Date	Site	Product	Classification	FEI
Sep 27, 2024	Rozzano, Italy	Drugs	Voluntary Action Indicated (VAI)	3002807260
Apr 7, 2023	Ceriano Laghetto, Italy	Drugs	Voluntary Action Indicated (VAI)	1000532829
Jan 31, 2020	Ceriano Laghetto, Italy	Drugs	Voluntary Action Indicated (VAI)	1000532829
Feb 28, 2019	Rozzano, Italy	Drugs	Voluntary Action Indicated (VAI)	3002807260
Jan 27, 2017	Rozzano, Italy	Drugs	Voluntary Action Indicated (VAI)	3002807260
May 12, 2016	Ceriano Laghetto, Italy	Drugs	Voluntary Action Indicated (VAI)	1000532829
Feb 27, 2015	Rozzano, Italy	Drugs	Voluntary Action Indicated (VAI)	3002807260
Jan 29, 2014	Rozzano, Italy	Drugs	Official Action Indicated (OAI)	3002807260
Nov 15, 2013	Ceriano Laghetto, Italy	Drugs	Voluntary Action Indicated (VAI)	1000532829
Jan 28, 2010	Rozzano, Italy	Drugs	No Action Indicated (NAI)	3002807260

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Trifarma S.P.A.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jul 7, 2014.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002807260	Rozzano, Italy	6	Sep 27, 2024
FEI 1000532829	Ceriano Laghetto, Italy	4	Apr 7, 2023

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