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Kyowa Hakko Bio Co., Ltd.

FDA Regulatory Profile

Kyowa Hakko Bio Co., Ltd. has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 2 compliance actions on record.

Latest inspection
Sep 20, 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
Inspections11Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 20, 2024Hofu, JapanDrugsNo Action Indicated (NAI)3002807424
Apr 15, 2022Hofu, JapanDrugsOfficial Action Indicated (OAI)3002807424
Nov 8, 2019Hofu, JapanDrugsOfficial Action Indicated (OAI)3002807424
Nov 8, 2019Ube, JapanDrugsNo Action Indicated (NAI)3002807425
Sep 15, 2017Ube, JapanDrugsVoluntary Action Indicated (VAI)3002807425
Sep 8, 2017Hofu, JapanDrugsOfficial Action Indicated (OAI)3002807424
Mar 20, 2014Hofu, JapanDrugsNo Action Indicated (NAI)3002807424
Mar 14, 2014Ube, JapanDrugsVoluntary Action Indicated (VAI)3002807425
Oct 27, 2011Hofu, JapanDrugsVoluntary Action Indicated (VAI)3002807424
Jul 2, 2010Ube, JapanDrugsVoluntary Action Indicated (VAI)3002807425
Jun 25, 2010Hofu, JapanDrugsOfficial Action Indicated (OAI)3002807424

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 3002807424Hofu, Japan7Sep 20, 2024
FEI 3002807425Ube, Japan4Nov 8, 2019

FDA data resources

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