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GraftSource, LLC

FDA Regulatory Profile

GraftSource, LLC has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 20, 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
Aug 20, 2025Grapevine, TXBiologicsNo Action Indicated (NAI)3005377075
Sep 19, 2019Grapevine, TXBiologicsNo Action Indicated (NAI)3005377075
Dec 5, 2017Grapevine, TXBiologicsNo Action Indicated (NAI)3005377075
Feb 6, 2014Grapevine, TXBiologicsNo Action Indicated (NAI)3005377075
Jan 11, 2012Grapevine, TXBiologicsVoluntary Action Indicated (VAI)3005377075

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 3005377075Grapevine, TX5Aug 20, 2025

FDA data resources

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