Sumitomo Pharma Co., Ltd.

FDA Regulatory Profile

Sumitomo Pharma Co., Ltd. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 7, 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
Inspections6Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 7, 2025Suzuka, JapanDrugsVoluntary Action Indicated (VAI)3003028650
Nov 22, 2019Suzuka, JapanDrugsVoluntary Action Indicated (VAI)3003028650
Jul 27, 2018Suzuka, JapanDrugsNo Action Indicated (NAI)3003028650
Sep 9, 2016Suzuka, JapanDrugsVoluntary Action Indicated (VAI)3003028650
Nov 1, 2013Suzuka, JapanDrugsVoluntary Action Indicated (VAI)3003028650
Feb 23, 2012Suzuka, JapanVeterinaryVoluntary Action Indicated (VAI)3003028650

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 3003028650Suzuka, Japan6Aug 7, 2025

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