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Opella Healthcare International SAS FDA Record

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

Latest inspection VAI · Jan 10, 2025
No warning letters matched by name

Inspections 6

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

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

What these totals cover: FDA records filed under the name "Opella Healthcare International SAS" and its spelling variant "Opella Healthcare International".

Latest inspection: Jan 10, 2025 · 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 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Opella Healthcare International SAS: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	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.

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Recent FDA inspections

6 inspections from Oct 21, 2011 to Jan 10, 2025.

Date	Site	Product	Classification	FEI
Jan 10, 2025	Compiegne, France	Drugs	Voluntary Action Indicated (VAI)	3003492806
Oct 31, 2019	Compiegne, France	Drugs	Voluntary Action Indicated (VAI)	3003492806
Jun 23, 2017	Compiegne, France	Drugs	Voluntary Action Indicated (VAI)	3003492806
Sep 18, 2015	Compiegne, France	Drugs	Voluntary Action Indicated (VAI)	3003492806
Sep 19, 2013	Compiegne, France	Drugs	Voluntary Action Indicated (VAI)	3003492806
Oct 21, 2011	Compiegne, France	Drugs	No Action Indicated (NAI)	3003492806

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 3003492806	Compiegne, France	6	Jan 10, 2025

Opella Healthcare International SAS and the FDA: common questions

Has Opella Healthcare International SAS received an FDA warning letter?

No FDA warning letter addressed to the name "Opella Healthcare International SAS" 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 Opella Healthcare International SAS received an FDA Form 483?

FDA has not published a Form 483 for "Opella Healthcare International SAS" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Opella Healthcare International SAS?

The most recent FDA inspection on file ended Jan 10, 2025 at Compiegne, France and was classified VAI. FDA has 6 inspections of Opella Healthcare International SAS on file.

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