Medart A /S

FDA Regulatory Profile

Medart A /S has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Medart A /S".

Latest inspection
Sep 24, 2015 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA inspections

3 inspections from Jun 1, 2012 to Sep 24, 2015.

DateSiteProductClassificationFEI
Sep 24, 2015Hvidovre, DenmarkDevicesNo Action Indicated (NAI)3005616124
Sep 13, 2013Hvidovre, DenmarkDevicesVoluntary Action Indicated (VAI)3005616124
Jun 1, 2012Hvidovre, DenmarkDevicesOfficial Action Indicated (OAI)3005616124
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Medart A /S: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Nov 19, 2012.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3005616124Hvidovre, Denmark3Sep 24, 2015

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