Daiichi Sankyo Europe GmbH

FDA Regulatory Profile

Daiichi Sankyo Europe GmbH has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 18, 2025 · 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
Inspections5Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 18, 2025Pfaffenhofen A.D.Ilm, GermanyDrugsVoluntary Action Indicated (VAI)3003282622
Oct 19, 2018Pfaffenhofen A.D.Ilm, GermanyDrugsNo Action Indicated (NAI)3003282622
May 15, 2014Pfaffenhofen A.D.Ilm, GermanyDrugsNo Action Indicated (NAI)3003282622
Sep 20, 2012Pfaffenhofen A.D.Ilm, GermanyDrugsNo Action Indicated (NAI)3003282622
Jan 29, 2010Pfaffenhofen A.D.Ilm, GermanyDrugsNo Action Indicated (NAI)3003282622

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 3003282622Pfaffenhofen A.D.Ilm, Germany5Jul 18, 2025

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