Hawaii Organ Procurement Organization

FDA Regulatory Profile

Hawaii Organ Procurement Organization has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 21, 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
Inspections5Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 21, 2025Honolulu, HIBiologicsNo Action Indicated (NAI)3000718303
Jun 14, 2018Honolulu, HIBiologicsNo Action Indicated (NAI)3000718303
May 13, 2016Honolulu, HIBiologicsNo Action Indicated (NAI)3000718303
Jan 24, 2013Honolulu, HIBiologicsNo Action Indicated (NAI)3000718303
Mar 22, 2011Honolulu, HIBiologicsVoluntary Action Indicated (VAI)3000718303

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 3000718303Honolulu, HI5Jul 21, 2025

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