Organon Heist

FDA Regulatory Profile

Organon Heist has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jan 30, 2023 · 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
Inspections8Nov 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—
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
Jan 30, 2023Heist-Op-Den-Berg, BelgiumDrugsVoluntary Action Indicated (VAI)3003974846
Jul 7, 2019Heist-Op-Den-Berg, BelgiumDrugsVoluntary Action Indicated (VAI)3003974846
Jun 30, 2017Heist-Op-Den-Berg, BelgiumDrugsNo Action Indicated (NAI)3003974846
Aug 19, 2016Heist-Op-Den-Berg, BelgiumDrugsNo Action Indicated (NAI)3003974846
Jun 19, 2015Heist-Op-Den-Berg, BelgiumDrugsVoluntary Action Indicated (VAI)3003974846
Sep 5, 2013Heist-Op-Den-Berg, BelgiumDevicesNo Action Indicated (NAI)3003974846
Oct 26, 2012Heist-Op-Den-Berg, BelgiumDrugsNo Action Indicated (NAI)3003974846
Mar 22, 2012Heist-Op-Den-Berg, BelgiumDrugsNo Action Indicated (NAI)3003974846

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 3003974846Heist-Op-Den-Berg, Belgium8Jan 30, 2023

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