Catalent France Beinheim SA FDA Record

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

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

What these totals cover: FDA records filed under the name "Catalent France Beinheim SA" and its spelling variant "Catalent France Beinheim". Records filed under related names are not included; see Related names.

Latest inspection
Nov 25, 2022 · 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

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

Catalent France Beinheim SA: FDA inspections per year 2017: 1 inspections120172018: 0 inspections020182019: 0 inspections020192020: 1 inspections120202021: 0 inspections020212022: 1 inspections120222023: 0 inspections020232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202300000
202210000
202100000
202010000
201900000
201800000
201710000

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 Sep 17, 2009 to Nov 25, 2022.

DateSiteProductClassificationFEI
Nov 25, 2022Beinheim, FranceDrugsVoluntary Action Indicated (VAI)3002808036
Oct 29, 2020Beinheim, FranceDrugsVoluntary Action Indicated (VAI)3002808036
Jul 21, 2017Beinheim, FranceDrugsVoluntary Action Indicated (VAI)3002808036
Mar 20, 2014Beinheim, FranceDrugsNo Action Indicated (NAI)3002808036
Jul 13, 2012Beinheim, FranceDrugsNo Action Indicated (NAI)3002808036
Sep 17, 2009Beinheim, FranceDrugsVoluntary Action Indicated (VAI)3002808036
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 3002808036Beinheim, France6Nov 25, 2022

Catalent France Beinheim SA and the FDA: common questions

Has Catalent France Beinheim SA received an FDA warning letter?

No FDA warning letter addressed to the name "Catalent France Beinheim SA" 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 Catalent France Beinheim SA received an FDA Form 483?

FDA has not published a Form 483 for "Catalent France Beinheim SA" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Catalent France Beinheim SA?

The most recent FDA inspection on file ended Nov 25, 2022 at Beinheim, France and was classified VAI. FDA has 6 inspections of Catalent France Beinheim SA on file.

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