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Daiichi Sankyo, Inc.

FDA Regulatory Profile

Daiichi Sankyo, Inc. has 0 FDA recalls, 15 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 4, 2026 · 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
Inspections15Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 4, 2026Basking Ridge, NJDrugsVoluntary Action Indicated (VAI)3003089536
Aug 1, 2025Basking Ridge, NJDrugsVoluntary Action Indicated (VAI)3003089536
Dec 22, 2023Iwaki, JapanDrugsVoluntary Action Indicated (VAI)3002808054
Nov 30, 2022Basking Ridge, NJDrugsNo Action Indicated (NAI)3003089536
Jul 15, 2022Basking Ridge, NJDrugsNo Action Indicated (NAI)3003089536
Apr 8, 2022Basking Ridge, NJDrugsNo Action Indicated (NAI)3003089536
Mar 30, 2021Basking Ridge, NJDrugsNo Action Indicated (NAI)3003089536
Jan 18, 2019Iwaki, JapanDrugsNo Action Indicated (NAI)3002808054
Jan 8, 2019Basking Ridge, NJDrugsVoluntary Action Indicated (VAI)3003089536
May 19, 2017Basking Ridge, NJDrugsNo Action Indicated (NAI)3003089536
Jul 2, 2015Iwaki, JapanDrugsNo Action Indicated (NAI)3002808054
Sep 9, 2014Basking Ridge, NJDrugsVoluntary Action Indicated (VAI)3003089536
Sep 20, 2012Chuo, JapanDrugsNo Action Indicated (NAI)3006222711
Jan 4, 2011Basking Ridge, NJDrugsVoluntary Action Indicated (VAI)3003089536
Aug 12, 2010Basking Ridge, NJDrugsNo Action Indicated (NAI)3003089536

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 3003089536Basking Ridge, NJ11May 4, 2026
FEI 3002808054Iwaki, Japan3Dec 22, 2023
FEI 3006222711Chuo, Japan1Sep 20, 2012

FDA data resources

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