Spera Nexus, Inc.

FDA Regulatory Profile

Spera Nexus, Inc. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 10, 2025 · 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
Inspections4Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 10, 2025Kakegawa, JapanDrugsNo Action Indicated (NAI)3002807324
Nov 1, 2019Kakegawa, JapanDrugsNo Action Indicated (NAI)3002807324
Jan 16, 2015Kakegawa, JapanDrugsVoluntary Action Indicated (VAI)3002807324
Apr 19, 2012Kakegawa, JapanDrugsNo Action Indicated (NAI)3002807324

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 3002807324Kakegawa, Japan4Jul 10, 2025

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