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U.S. Infusion, LLC

FDA Regulatory Profile

U.S. Infusion, LLC has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Jul 28, 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
Inspections4Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 28, 2025South Miami, FLDevicesNo Action Indicated (NAI)3008782867
Mar 6, 2023South Miami, FLDevicesVoluntary Action Indicated (VAI)3008782867
Sep 3, 2015South Miami, FLDevicesNo Action Indicated (NAI)3008782867
Sep 17, 2014South Miami, FLDevicesOfficial Action Indicated (OAI)3008782867

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 3008782867South Miami, FL4Jul 28, 2025

FDA data resources

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