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Hisamitsu Pharmaceutical Co., Inc.

FDA Regulatory Profile

Hisamitsu Pharmaceutical Co., Inc. has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 11, 2025 · VAI

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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
Inspections9Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 11, 2025Utsunomiya, JapanDrugsVoluntary Action Indicated (VAI)3008742780
Jul 4, 2025Tosu, JapanDrugsVoluntary Action Indicated (VAI)1000266995
Oct 11, 2019Utsunomiya, JapanDrugsVoluntary Action Indicated (VAI)3008742780
May 31, 2019Tosu, JapanDrugsVoluntary Action Indicated (VAI)1000266995
Sep 15, 2017Tosu, JapanDrugsVoluntary Action Indicated (VAI)1000266995
Jan 20, 2017Utsunomiya, JapanDrugsVoluntary Action Indicated (VAI)3008742780
Apr 11, 2014Tosu, JapanDrugsVoluntary Action Indicated (VAI)1000266995
Feb 17, 2012Tosu, JapanDrugsVoluntary Action Indicated (VAI)1000266995
Apr 1, 2009Tosu, JapanDrugsNo Action Indicated (NAI)1000266995

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 3008742780Utsunomiya, Japan3Jul 11, 2025
FEI 1000266995Tosu, Japan6Jul 4, 2025

FDA data resources

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