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Grifols Diagnostic Solutions, Inc.

FDA Regulatory Profile

Grifols Diagnostic Solutions, Inc. has 0 FDA recalls, 25 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 31, 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
Inspections25Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 31, 2025Emeryville, CABiologicsVoluntary Action Indicated (VAI)1000124057
Aug 26, 2025San Diego, CABiologicsVoluntary Action Indicated (VAI)3003460312
Dec 13, 2024Emeryville, CABiologicsVoluntary Action Indicated (VAI)1000124057
Feb 17, 2022San Diego, CABiologicsNo Action Indicated (NAI)3003460312
Dec 7, 2021Emeryville, CABiologicsNo Action Indicated (NAI)1000124057
Feb 15, 2019Emeryville, CABiologicsVoluntary Action Indicated (VAI)1000124057
Dec 10, 2018San Diego, CADevicesNo Action Indicated (NAI)3003460312
Nov 14, 2017San Diego, CABiologicsVoluntary Action Indicated (VAI)3014271959
Nov 9, 2017San Diego, CABiologicsNo Action Indicated (NAI)3003460312
Sep 28, 2016Emeryville, CABiologicsVoluntary Action Indicated (VAI)1000124057
Jun 30, 2016San Diego, CADevicesNo Action Indicated (NAI)3003460312
Jan 18, 2016San Diego, CABiologicsVoluntary Action Indicated (VAI)3003460312
Jan 29, 2014Emeryville, CABiologicsNo Action Indicated (NAI)1000124057
Dec 3, 2013San Diego, CADevicesNo Action Indicated (NAI)3003460312
May 20, 2013San Diego, CABiologicsNo Action Indicated (NAI)3003460312
May 10, 2013Emeryville, CADrugsVoluntary Action Indicated (VAI)1000124057
Jan 25, 2013San Diego, CADevicesNo Action Indicated (NAI)3003460312
Jan 25, 2013San Diego, CADevicesNo Action Indicated (NAI)3003460312
May 24, 2012Emeryville, CABiologicsOfficial Action Indicated (OAI)1000124057
Mar 30, 2012Emeryville, CADevicesNo Action Indicated (NAI)1000124057

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 1000124057Emeryville, CA12Oct 31, 2025
FEI 3003460312San Diego, CA12Aug 26, 2025
FEI 3014271959San Diego, CA1Nov 14, 2017

FDA data resources

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