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Astellas Pharma Inc.

FDA Regulatory Profile

Astellas Pharma Inc. has 0 FDA recalls, 18 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 6, 2025 · VAI

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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
Inspections18Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 6, 2025Takahagi, JapanDrugsVoluntary Action Indicated (VAI)3002808523
Jun 6, 2025Takaoka, JapanDrugsVoluntary Action Indicated (VAI)3002807001
Apr 18, 2024Toyama, JapanDrugsNo Action Indicated (NAI)3002807003
Oct 27, 2023Yaizu, JapanDrugsVoluntary Action Indicated (VAI)3002809620
May 31, 2019Toyama, JapanDrugsNo Action Indicated (NAI)3002807003
Mar 5, 2019Takaoka, JapanDrugsVoluntary Action Indicated (VAI)3002807001
Dec 13, 2018Takahagi, JapanDrugsNo Action Indicated (NAI)3002808523
Nov 11, 2016Toyama, JapanDrugsVoluntary Action Indicated (VAI)3002807003
Mar 18, 2016Takaoka, JapanDrugsNo Action Indicated (NAI)3002807001
Mar 7, 2016Yaizu, JapanDrugsNo Action Indicated (NAI)3002809620
Jun 27, 2014Takahagi, JapanDrugsNo Action Indicated (NAI)3002808523
Jun 25, 2014Toyama, JapanDrugsNo Action Indicated (NAI)3002807003
Apr 11, 2014Takaoka, JapanDrugsVoluntary Action Indicated (VAI)3002807001
Feb 10, 2012Toyama, JapanDrugsNo Action Indicated (NAI)3002807003
Nov 21, 2011Takaoka, JapanDrugsVoluntary Action Indicated (VAI)3002807001
Oct 15, 2009Takahagi, JapanDrugsVoluntary Action Indicated (VAI)3002808523
Nov 7, 2008Takaoka, JapanDrugsVoluntary Action Indicated (VAI)3002807001
Oct 31, 2008Toyama, JapanDrugsVoluntary Action Indicated (VAI)3002807003

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 3002807001Takaoka, Japan6Jun 6, 2025
FEI 3002808523Takahagi, Japan4Jun 6, 2025
FEI 3002807003Toyama, Japan6Apr 18, 2024
FEI 3002809620Yaizu, Japan2Oct 27, 2023

FDA data resources

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