Organon Pharma (UK) Ltd.

FDA Regulatory Profile

Organon Pharma (UK) Ltd. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 13, 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
Inspections5Nov 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)
Msd International
Same company group
00150—
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—
Intervet Gesmbh
Same company group
0040—
Merck
Same company group
0040—

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 13, 2025Cramlington, United KingdomDrugsVoluntary Action Indicated (VAI)3002807653
Jun 14, 2018Cramlington, United KingdomDrugsVoluntary Action Indicated (VAI)3002807653
Feb 6, 2015Cramlington, United KingdomDrugsNo Action Indicated (NAI)3002807653
Mar 22, 2013Cramlington, United KingdomDrugsVoluntary Action Indicated (VAI)3002807653
Mar 9, 2010Cramlington, United KingdomDrugsNo Action Indicated (NAI)3002807653

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 3002807653Cramlington, United Kingdom5Jun 13, 2025

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