Catalent Germany Eberbach GmbH

FDA Regulatory Profile

Catalent Germany Eberbach GmbH has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 2, 2024 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections7Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
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Catalent Massachusetts
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Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 2, 2024Eberbach, GermanyDrugsVoluntary Action Indicated (VAI)3002808098
Sep 6, 2019Eberbach, GermanyDrugsNo Action Indicated (NAI)3002808098
Mar 2, 2018Eberbach, GermanyDrugsNo Action Indicated (NAI)3002808098
Mar 18, 2016Eberbach, GermanyDrugsNo Action Indicated (NAI)3002808098
Sep 12, 2013Eberbach, GermanyDrugsNo Action Indicated (NAI)3002808098
Feb 8, 2013Eberbach, GermanyFood/CosmeticsNo Action Indicated (NAI)3002808098
Mar 5, 2010Eberbach, GermanyDrugsVoluntary Action Indicated (VAI)3002808098

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3002808098Eberbach, Germany7Feb 2, 2024

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