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Chugai Pharma Manufacturing Co. Ltd.

FDA Regulatory Profile

Chugai Pharma Manufacturing Co. Ltd. has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 4, 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 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 4, 2025Fujieda, JapanDrugsVoluntary Action Indicated (VAI)3002806758
Apr 2, 2024Utsunomiya, JapanDrugsVoluntary Action Indicated (VAI)3006942691
Sep 26, 2019Utsunomiya, JapanDrugsVoluntary Action Indicated (VAI)3006942691
Aug 30, 2019Fujieda, JapanDrugsVoluntary Action Indicated (VAI)3002806758
Nov 10, 2017Utsunomiya, JapanDrugsVoluntary Action Indicated (VAI)3006942691
Mar 24, 2015Utsunomiya, JapanDrugsNo Action Indicated (NAI)3006942691
Mar 15, 2013Utsunomiya, JapanDrugsNo Action Indicated (NAI)3006942691
Feb 1, 2011Utsunomiya, JapanDrugsVoluntary Action Indicated (VAI)3006942691
Jun 11, 2010Utsunomiya, JapanDrugsNo Action Indicated (NAI)3006942691

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 3002806758Fujieda, Japan2Jul 4, 2025
FEI 3006942691Utsunomiya, Japan7Apr 2, 2024

FDA data resources

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