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Flott S.P.A. FDA Record

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

Flott S.P.A. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Flott S.P.A., the most recent on Jan 30, 2018.

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

Latest inspection: Apr 12, 2019 · NAI

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	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Flott 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	Warning letters
2026	0	0
2025	0	0
2024	0	0
2023	0	0
2022	0	0
2021	0	0
2020	0	0
2019	1	0
2018	0	1
2017	1	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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Flott S.P.A. FDA Warning Letters

1 warning letter on Jan 30, 2018.

Issued	Subject	Issuing office	Close-out letter
Jan 30, 2018

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

3 inspections from Feb 14, 2012 to Apr 12, 2019.

Date	Site	Product	Classification	FEI
Apr 12, 2019	Bagheria, Italy	Food/Cosmetics	No Action Indicated (NAI)	1000245869
Oct 24, 2017	Bagheria, Italy	Food/Cosmetics	Voluntary Action Indicated (VAI)	1000245869
Feb 14, 2012	Bagheria, Italy	Food/Cosmetics	No Action Indicated (NAI)	1000245869

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 Flott S.P.A.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jan 30, 2018.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1000245869	Bagheria, Italy	3	Apr 12, 2019

Flott S.P.A. and the FDA: common questions

Has Flott S.P.A. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Flott S.P.A.. The most recent is dated Jan 30, 2018.

Has Flott S.P.A. received an FDA Form 483?

FDA has not published a Form 483 for "Flott S.P.A." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Flott S.P.A.?

The most recent FDA inspection on file ended Apr 12, 2019 at Bagheria, Italy and was classified NAI. FDA has 3 inspections of Flott S.P.A. on file.

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