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Fareva Mirabel FDA Record

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

Fareva Mirabel has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Fareva Mirabel" is on file.

What these totals cover: FDA records filed under the name "Fareva Mirabel".

Latest inspection: Jul 22, 2022 · 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	6	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

Fareva Mirabel'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	0	0	0	0	0
2023	0	0	0	0	0
2022	1	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	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

6 inspections from May 23, 2011 to Jul 22, 2022.

Date	Site	Product	Classification	FEI
Jul 22, 2022	Riom, France	Drugs	Voluntary Action Indicated (VAI)	1000173162
Mar 15, 2019	Riom, France	Drugs	Voluntary Action Indicated (VAI)	1000173162
Jun 8, 2018	Riom, France	Drugs	Voluntary Action Indicated (VAI)	1000173162
Jan 19, 2016	Riom, France	Drugs	Voluntary Action Indicated (VAI)	1000173162
May 22, 2014	Riom, France	Drugs	Voluntary Action Indicated (VAI)	1000173162
May 23, 2011	Riom, France	Drugs	Voluntary Action Indicated (VAI)	1000173162

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 1000173162	Riom, France	6	Jul 22, 2022

Fareva Mirabel and the FDA: common questions

Has Fareva Mirabel received an FDA warning letter?

No FDA warning letter addressed to the name "Fareva Mirabel" 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 Fareva Mirabel received an FDA Form 483?

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

When did the FDA last inspect Fareva Mirabel?

The most recent FDA inspection on file ended Jul 22, 2022 at Riom, France and was classified VAI. FDA has 6 inspections of Fareva Mirabel on file.

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