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Shionogi Pharma Co., Ltd.

FDA Regulatory Profile

Shionogi Pharma Co., Ltd. has 0 FDA recalls, 16 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 1, 2025 · OAI

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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
Inspections16Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 1, 2025Isawa-Gun, JapanDrugsOfficial Action Indicated (OAI)3002808135
May 30, 2025Settsu, JapanDrugsVoluntary Action Indicated (VAI)3004544937
Apr 5, 2024Amagasaki, JapanDrugsNo Action Indicated (NAI)3006396183
Oct 20, 2023Tokushima, JapanDrugsVoluntary Action Indicated (VAI)3008353674
Feb 28, 2019Settsu, JapanDrugsNo Action Indicated (NAI)3004544937
Sep 28, 2018Isawa-Gun, JapanDrugsNo Action Indicated (NAI)3002808135
Sep 16, 2016Isawa-Gun, JapanDrugsVoluntary Action Indicated (VAI)3002808135
Sep 16, 2016Isawa-Gun, JapanDrugsNo Action Indicated (NAI)3002808135
Jun 3, 2016Amagasaki, JapanDrugsVoluntary Action Indicated (VAI)3006396183
Dec 4, 2015Tokushima, JapanDrugsNo Action Indicated (NAI)3008353674
Apr 1, 2014Isawa-Gun, JapanDrugsVoluntary Action Indicated (VAI)3002808135
Feb 15, 2012Amagasaki, JapanDrugsVoluntary Action Indicated (VAI)3006396183
Feb 15, 2012Amagasaki, JapanDrugsNo Action Indicated (NAI)3006396183
Feb 9, 2012Tokushima, JapanDrugsVoluntary Action Indicated (VAI)3008353674
Feb 2, 2012Isawa-Gun, JapanDrugsNo Action Indicated (NAI)3002808135
Jul 26, 2010Isawa-Gun, JapanDrugsVoluntary Action Indicated (VAI)3002808135

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 3002808135Isawa-Gun, Japan7Jul 1, 2025
FEI 3004544937Settsu, Japan2May 30, 2025
FEI 3006396183Amagasaki, Japan4Apr 5, 2024
FEI 3008353674Tokushima, Japan3Oct 20, 2023

FDA data resources

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