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Structure Medical LLC

FDA Regulatory Profile

Structure Medical LLC has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 11, 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
Inspections9Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 11, 2025Mooresville, NCDevicesNo Action Indicated (NAI)3007993775
Jan 19, 2024Naples, FLDevicesNo Action Indicated (NAI)3009322142
Jul 17, 2023Madison, ALDevicesNo Action Indicated (NAI)3009883317
May 5, 2023Mooresville, NCDevicesNo Action Indicated (NAI)3007993775
Feb 15, 2018Madison, ALDevicesNo Action Indicated (NAI)3009883317
Jul 11, 2017Mooresville, NCDevicesNo Action Indicated (NAI)3007993775
Mar 3, 2017Naples, FLDevicesVoluntary Action Indicated (VAI)3009322142
Nov 21, 2014Naples, FLDevicesVoluntary Action Indicated (VAI)3009322142
Aug 1, 2014Naples, FLDevicesVoluntary Action Indicated (VAI)3009322142

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 3007993775Mooresville, NC3Sep 11, 2025
FEI 3009322142Naples, FL4Jan 19, 2024
FEI 3009883317Madison, AL2Jul 17, 2023

FDA data resources

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