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Takeda Pharmaceutical Company Limited

FDA Regulatory Profile

Takeda Pharmaceutical Company Limited has 0 FDA recalls, 26 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Apr 12, 2024 · NAI

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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
Inspections26Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 12, 2024Yodogawa-Ku, JapanDrugsNo Action Indicated (NAI)3002808311
Nov 6, 2023Hikari, JapanDrugsVoluntary Action Indicated (VAI)3004664162
Jul 19, 2021Hikari, JapanDrugsVoluntary Action Indicated (VAI)3004664162
Nov 26, 2019Hikari, JapanDrugsOfficial Action Indicated (OAI)3004664162
Aug 9, 2019Yodogawa-Ku, JapanDrugsVoluntary Action Indicated (VAI)3002808311
Jul 30, 2019Ammon, IDBiologicsNo Action Indicated (NAI)3006611178
Jun 27, 2019Fayetteville, ARBiologicsNo Action Indicated (NAI)3000204650
Nov 7, 2017Hikari, JapanDrugsNo Action Indicated (NAI)3004664162
Aug 29, 2017Yodogawa-Ku, JapanDrugsNo Action Indicated (NAI)3002808311
Jun 16, 2016Fayetteville, ARBiologicsNo Action Indicated (NAI)3000204650
Jun 15, 2016Ammon, IDBiologicsNo Action Indicated (NAI)3006611178
Oct 30, 2015Hikari, JapanDrugsVoluntary Action Indicated (VAI)3004664162
Sep 18, 2015Yodogawa-Ku, JapanDrugsVoluntary Action Indicated (VAI)3002808311
Jul 9, 2015Ammon, IDBiologicsNo Action Indicated (NAI)3006611178
Sep 18, 2014Fayetteville, ARBiologicsNo Action Indicated (NAI)3000204650
Sep 18, 2013Hikari, JapanDrugsVoluntary Action Indicated (VAI)3004664162
Sep 6, 2013Yodogawa-Ku, JapanDrugsVoluntary Action Indicated (VAI)3002808311
Aug 14, 2013Ammon, IDBiologicsNo Action Indicated (NAI)3006611178
Aug 2, 2012Yodogawa-Ku, JapanDrugsVoluntary Action Indicated (VAI)3002808311
Jul 20, 2012Hikari, JapanDrugsVoluntary Action Indicated (VAI)3004664162

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 3002808311Yodogawa-Ku, Japan7Apr 12, 2024
FEI 3004664162Hikari, Japan9Nov 6, 2023
FEI 3006611178Ammon, ID6Jul 30, 2019
FEI 3000204650Fayetteville, AR4Jun 27, 2019

FDA data resources

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