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CryoGam Colorado, LLC.

FDA Regulatory Profile

CryoGam Colorado, LLC. has 0 FDA recalls, 15 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 9, 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
Inspections15Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 9, 2025Boulder, COBiologicsNo Action Indicated (NAI)3010133657
Sep 9, 2025Denver, COBiologicsNo Action Indicated (NAI)3010131527
Jul 23, 2025Loveland, COBiologicsNo Action Indicated (NAI)3004092640
Jan 10, 2023Loveland, COBiologicsNo Action Indicated (NAI)3004092640
Jan 8, 2020Boulder, COBiologicsNo Action Indicated (NAI)3010133657
Mar 5, 2019Denver, COBiologicsNo Action Indicated (NAI)3010131527
Aug 15, 2018Loveland, COBiologicsNo Action Indicated (NAI)3004092640
Feb 7, 2018Boulder, COBiologicsNo Action Indicated (NAI)3010133657
Jul 28, 2017Loveland, COBiologicsVoluntary Action Indicated (VAI)3004092640
Nov 8, 2016Denver, COBiologicsNo Action Indicated (NAI)3010131527
Feb 11, 2015Boulder, COBiologicsNo Action Indicated (NAI)3010133657
Dec 9, 2014Denver, COBiologicsNo Action Indicated (NAI)3010131527
Nov 5, 2012Loveland, COBiologicsNo Action Indicated (NAI)3004092640
May 24, 2011Loveland, COBiologicsNo Action Indicated (NAI)3004092640
Nov 19, 2008Loveland, COBiologicsVoluntary Action Indicated (VAI)3004092640

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 3010131527Denver, CO4Sep 9, 2025
FEI 3010133657Boulder, CO4Sep 9, 2025
FEI 3004092640Loveland, CO7Jul 23, 2025

FDA data resources

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