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SkyePharma Production SAS FDA Record

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

Latest inspection VAI · Oct 27, 2023
No warning letters matched by name

Inspections 5

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

SkyePharma Production SAS has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "SkyePharma Production SAS" is on file.

What these totals cover: FDA records filed under the name "SkyePharma Production SAS" and its spelling variant "Skyepharma Production".

Latest inspection: Oct 27, 2023 · 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	5	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

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

SkyePharma Production SAS: 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	0	0	0	0	0
2023	1	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	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

5 inspections from Apr 2, 2010 to Oct 27, 2023.

Date	Site	Product	Classification	FEI
Oct 27, 2023	St Quentin Fallavier, France	Drugs	Voluntary Action Indicated (VAI)	3002808180
Sep 6, 2019	St Quentin Fallavier, France	Drugs	No Action Indicated (NAI)	3002808180
Jun 19, 2015	St Quentin Fallavier, France	Drugs	No Action Indicated (NAI)	3002808180
May 31, 2013	St Quentin Fallavier, France	Drugs	No Action Indicated (NAI)	3002808180
Apr 2, 2010	St Quentin Fallavier, France	Drugs	Voluntary Action Indicated (VAI)	3002808180

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 3002808180	St Quentin Fallavier, France	5	Oct 27, 2023

SkyePharma Production SAS and the FDA: common questions

Has SkyePharma Production SAS received an FDA warning letter?

No FDA warning letter addressed to the name "SkyePharma Production 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 SkyePharma Production SAS received an FDA Form 483?

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

When did the FDA last inspect SkyePharma Production SAS?

The most recent FDA inspection on file ended Oct 27, 2023 at St Quentin Fallavier, France and was classified VAI. FDA has 5 inspections of SkyePharma Production SAS on file.

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