Roquette Freres FDA Record

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

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

What these totals cover: FDA records filed under the name "Roquette Freres".

Latest inspection
Jul 21, 2023 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections6Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Roquette Freres: FDA inspections per year 2017: 2 inspections220172018: 0 inspections020182019: 0 inspections020192020: 1 inspections120202021: 0 inspections020212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
202200000
202100000
202010000
201900000
201800000
201720000

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 23, 2012 to Jul 21, 2023.

DateSiteProductClassificationFEI
Jul 21, 2023Lestrem, FranceDrugsVoluntary Action Indicated (VAI)1000114558
Dec 4, 2020Lestrem, FranceDrugsVoluntary Action Indicated (VAI)1000114558
Nov 10, 2017Lestrem, FranceDrugsVoluntary Action Indicated (VAI)1000114558
Feb 10, 2017Lestrem, FranceDrugsVoluntary Action Indicated (VAI)1000114558
May 29, 2015Lestrem, FranceDrugsVoluntary Action Indicated (VAI)1000114558
Oct 23, 2012Lestrem, FranceDrugsNo Action Indicated (NAI)1000114558
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.

FacilityLocationInspectionsLatest
FEI 1000114558Lestrem, France6Jul 21, 2023

Roquette Freres and the FDA: common questions

Has Roquette Freres received an FDA warning letter?

No FDA warning letter addressed to the name "Roquette Freres" 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 Roquette Freres received an FDA Form 483?

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

When did the FDA last inspect Roquette Freres?

The most recent FDA inspection on file ended Jul 21, 2023 at Lestrem, France and was classified VAI. FDA has 6 inspections of Roquette Freres on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.