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Ono Pharmaceutical Co., Ltd.

FDA Regulatory Profile

Ono Pharmaceutical Co., Ltd. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 27, 2025 · NAI

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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
Inspections4Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 27, 2025Fujinomiya, JapanDrugsNo Action Indicated (NAI)3002807805
Dec 21, 2018Fujinomiya, JapanDrugsVoluntary Action Indicated (VAI)3002807805
Jan 30, 2014Fujinomiya, JapanDrugsNo Action Indicated (NAI)3002807805
Feb 8, 2011Osaka, JapanDrugsNo Action Indicated (NAI)3002807806

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 3002807805Fujinomiya, Japan3Jun 27, 2025
FEI 3002807806Osaka, Japan1Feb 8, 2011

FDA data resources

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