MSD International GmbH

FDA Regulatory Profile

MSD International GmbH has 0 FDA recalls, 15 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 11, 2025 · VAI

Newer recall under related name Merck Sharp And Dohme: Dec 12, 2025, D-0242-2026.

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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
Inspections15Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Merck Sharp And Dohme
Same company group
50590Dec 12, 2025 (D-0242-2026)
Organon
Same company group
34200May 28, 2024 (D-0552-2024)
Organon Teknika
Same company group
113000Jan 11, 2019 (Z-0962-2019)
Cubist Pharmaceuticals
Same company group
4000Aug 8, 2014 (D-0229-2015)
Merck And Cie
Same company group
0080—
Organon Heist
Same company group
0080—
Intervet International
Same company group
0051—
Intervet
Same company group
0050—
Intervet Production
Same company group
0050—
Organon Pharma (Uk)
Same company group
0050—
Intervet Gesmbh
Same company group
0040—
Merck
Same company group
0040—

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 11, 2025Co. Cork, IrelandBiologicsVoluntary Action Indicated (VAI)3002808087
Feb 17, 2025Clonmel, IrelandDrugsVoluntary Action Indicated (VAI)3002807560
Nov 8, 2024Swords, IrelandDrugsVoluntary Action Indicated (VAI)3017657338
Mar 24, 2023Clonmel, IrelandDrugsVoluntary Action Indicated (VAI)3002807560
May 13, 2022Clonmel, IrelandDrugsVoluntary Action Indicated (VAI)3002807560
Dec 3, 2021Swords, IrelandDrugsVoluntary Action Indicated (VAI)3017657338
May 18, 2018Co. Cork, IrelandDrugsVoluntary Action Indicated (VAI)3002808087
Jun 14, 2016Co. Cork, IrelandDrugsNo Action Indicated (NAI)3002808087
Feb 4, 2014Co. Cork, IrelandDrugsNo Action Indicated (NAI)3002808087
May 16, 2013Clonmel, IrelandDrugsNo Action Indicated (NAI)3002807560
Mar 15, 2013Clonmel, IrelandDrugsNo Action Indicated (NAI)3002807560
Feb 5, 2013Co. Cork, IrelandDrugsNo Action Indicated (NAI)3002808087
May 5, 2011Clonmel, IrelandDrugsNo Action Indicated (NAI)3002807560
Nov 18, 2010Co. Cork, IrelandDrugsVoluntary Action Indicated (VAI)3002808087
May 27, 2010Clonmel, IrelandDrugsNo Action Indicated (NAI)3002807560

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 3002808087Co. Cork, Ireland6Apr 11, 2025
FEI 3002807560Clonmel, Ireland7Feb 17, 2025
FEI 3017657338Swords, Ireland2Nov 8, 2024

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