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Astrea Fontaine FDA Record

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

Latest inspection VAI · Sep 13, 2024
No warning letters matched by name

Inspections 4

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Astrea Fontaine has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Astrea Fontaine" is on file.

What these totals cover: FDA records filed under the name "Astrea Fontaine".

Latest inspection: Sep 13, 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	4	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

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

Astrea Fontaine: 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	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	1	0	0	0	0
2019	0	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.

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Recent FDA inspections

4 inspections from Jan 22, 2016 to Sep 13, 2024.

Date	Site	Product	Classification	FEI
Sep 13, 2024	Fontaine Les Dijon, France	Drugs	Voluntary Action Indicated (VAI)	3002807473
Dec 11, 2020	Fontaine Les Dijon, France	Drugs	Voluntary Action Indicated (VAI)	3002807473
Nov 10, 2017	Fontaine Les Dijon, France	Drugs	Voluntary Action Indicated (VAI)	3002807473
Jan 22, 2016	Fontaine Les Dijon, France	Drugs	Voluntary Action Indicated (VAI)	3002807473

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 3002807473	Fontaine Les Dijon, France	4	Sep 13, 2024

Astrea Fontaine and the FDA: common questions

Has Astrea Fontaine received an FDA warning letter?

No FDA warning letter addressed to the name "Astrea Fontaine" 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 Astrea Fontaine received an FDA Form 483?

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

When did the FDA last inspect Astrea Fontaine?

The most recent FDA inspection on file ended Sep 13, 2024 at Fontaine Les Dijon, France and was classified VAI. FDA has 4 inspections of Astrea Fontaine on file.

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