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Nippon Shikizai, Inc.

FDA Regulatory Profile

Nippon Shikizai, Inc. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 12, 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
Inspections5Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 12, 2025Tsukuba, JapanDrugsVoluntary Action Indicated (VAI)3012051074
Aug 6, 2019Tsukuba, JapanDrugsVoluntary Action Indicated (VAI)3012051074
Aug 3, 2018Zama, JapanDrugsVoluntary Action Indicated (VAI)3001651340
Jun 26, 2015Zama, JapanDrugsVoluntary Action Indicated (VAI)3001651340
Feb 16, 2012Zama, JapanDrugsVoluntary Action Indicated (VAI)3001651340

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 3012051074Tsukuba, Japan2Sep 12, 2025
FEI 3001651340Zama, Japan3Aug 3, 2018

FDA data resources

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