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One Blood Inc

FDA Regulatory Profile

One Blood Inc has 0 FDA recalls, 15 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 15, 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
Inspections15Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 15, 2025Concord, NCBiologicsVoluntary Action Indicated (VAI)3009064248
Sep 11, 2025Charlotte, NCBiologicsNo Action Indicated (NAI)3004054586
Jun 25, 2024Charlotte, NCBiologicsNo Action Indicated (NAI)3014918942
Nov 30, 2022Charlotte, NCBiologicsNo Action Indicated (NAI)3004054586
Jan 16, 2020Charlotte, NCBiologicsNo Action Indicated (NAI)3014918942
May 17, 2019Charlotte, NCBiologicsNo Action Indicated (NAI)3004054586
Jan 31, 2018Concord, NCBiologicsNo Action Indicated (NAI)3009064248
May 5, 2017Charlotte, NCBiologicsNo Action Indicated (NAI)3004054586
Jun 14, 2016Concord, NCBiologicsNo Action Indicated (NAI)3009064248
May 1, 2015Charlotte, NCBiologicsNo Action Indicated (NAI)3004054586
Jun 13, 2014Concord, NCBiologicsNo Action Indicated (NAI)3009064248
Apr 12, 2013Charlotte, NCBiologicsVoluntary Action Indicated (VAI)3004054586
May 10, 2012Concord, NCBiologicsNo Action Indicated (NAI)3009064248
Jun 9, 2011Charlotte, NCBiologicsNo Action Indicated (NAI)3004054586
Jun 24, 2010Charlotte, NCBiologicsVoluntary Action Indicated (VAI)3004054586

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 3009064248Concord, NC5Dec 15, 2025
FEI 3004054586Charlotte, NC8Sep 11, 2025
FEI 3014918942Charlotte, NC2Jun 25, 2024

FDA data resources

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