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Flamma SpA FDA Record

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

Latest inspection VAI · Nov 22, 2024
No warning letters matched by name

Inspections 12

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Flamma SpA has 0 FDA recalls, 12 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Flamma SpA" is on file.

What these totals cover: FDA records filed under the name "Flamma SpA" and its spelling variant "Flamma".

Latest inspection: Nov 22, 2024 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	12	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Flamma SpA's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Flamma SpA: FDA inspections per year

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	2	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	1	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.

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Recent FDA inspections

12 inspections from Oct 29, 2009 to Nov 22, 2024.

Date	Site	Product	Classification	FEI
Nov 22, 2024	Chignolo D'Isola, Italy	Drugs	Voluntary Action Indicated (VAI)	3001168779
Dec 15, 2023	Bulciago, Italy	Drugs	Voluntary Action Indicated (VAI)	3002806311
Apr 15, 2022	Isso, Italy	Drugs	Voluntary Action Indicated (VAI)	3003974261
Mar 25, 2022	Chignolo D'Isola, Italy	Drugs	Voluntary Action Indicated (VAI)	3001168779
Jul 26, 2019	Bulciago, Italy	Drugs	Voluntary Action Indicated (VAI)	3002806311
Sep 21, 2018	Bulciago, Italy	Drugs	Voluntary Action Indicated (VAI)	3002806311
Mar 17, 2017	Chignolo D'Isola, Italy	Drugs	Voluntary Action Indicated (VAI)	3001168779
May 20, 2016	Chignolo D'Isola, Italy	Drugs	Voluntary Action Indicated (VAI)	3001168779
Mar 21, 2014	Chignolo D'Isola, Italy	Drugs	Voluntary Action Indicated (VAI)	3001168779
Mar 13, 2014	Bulciago, Italy	Drugs	No Action Indicated (NAI)	3002806311
Feb 3, 2011	Bulciago, Italy	Drugs	Voluntary Action Indicated (VAI)	3002806311
Oct 29, 2009	Chignolo D'Isola, Italy	Drugs	Voluntary Action Indicated (VAI)	3001168779

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

3 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3001168779	Chignolo D'Isola, Italy	6	Nov 22, 2024
FEI 3002806311	Bulciago, Italy	5	Dec 15, 2023
FEI 3003974261	Isso, Italy	1	Apr 15, 2022

Flamma SpA and the FDA: common questions

Has Flamma SpA received an FDA warning letter?

No FDA warning letter addressed to the name "Flamma SpA" 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 Flamma SpA received an FDA Form 483?

FDA has not published a Form 483 for "Flamma SpA" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Flamma SpA?

The most recent FDA inspection on file ended Nov 22, 2024 at Chignolo D'Isola, Italy and was classified VAI. FDA has 12 inspections of Flamma SpA on file.

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