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Eurofins Donor & Product Testing LLC

FDA Regulatory Profile

Eurofins Donor & Product Testing LLC has 0 FDA recalls, 24 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 15, 2026 · 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
Inspections24Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 15, 2026Honolulu, HIBiologicsNo Action Indicated (NAI)3017535189
Dec 12, 2025Philadelphia, PABiologicsNo Action Indicated (NAI)3007203928
Jun 27, 2025Winston Salem, NCBiologicsNo Action Indicated (NAI)3015976668
Mar 26, 2025Irwindale, CABiologicsNo Action Indicated (NAI)3004732463
Jul 19, 2024Centennial, COBiologicsVoluntary Action Indicated (VAI)1000477683
Jun 9, 2023Honolulu, HIBiologicsNo Action Indicated (NAI)3017535189
Feb 17, 2023Philadelphia, PABiologicsNo Action Indicated (NAI)3007203928
Sep 22, 2021Winston Salem, NCBiologicsNo Action Indicated (NAI)3015976668
Aug 28, 2019Philadelphia, PABiologicsNo Action Indicated (NAI)3007203928
May 17, 2019Centennial, COBiologicsNo Action Indicated (NAI)1000477683
Nov 8, 2018Centennial, COBiologicsNo Action Indicated (NAI)1000477683
Jun 9, 2017Centennial, COBiologicsNo Action Indicated (NAI)1000477683
Aug 23, 2016Irwindale, CABiologicsNo Action Indicated (NAI)3004732463
Jun 9, 2016Philadelphia, PABiologicsNo Action Indicated (NAI)3007203928
Feb 19, 2016Centennial, COBiologicsVoluntary Action Indicated (VAI)1000477683
Apr 21, 2014Philadelphia, PABiologicsNo Action Indicated (NAI)3007203928
Apr 18, 2014Centennial, COBiologicsNo Action Indicated (NAI)1000477683
Jan 14, 2014Centennial, COBiologicsVoluntary Action Indicated (VAI)1000477683
Sep 14, 2012Philadelphia, PABiologicsNo Action Indicated (NAI)3007203928
Mar 15, 2012Centennial, COBiologicsVoluntary Action Indicated (VAI)1000477683

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 3017535189Honolulu, HI2May 15, 2026
FEI 3007203928Philadelphia, PA7Dec 12, 2025
FEI 3015976668Winston Salem, NC2Jun 27, 2025
FEI 3004732463Irwindale, CA3Mar 26, 2025
FEI 1000477683Centennial, CO10Jul 19, 2024

FDA data resources

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