Dornier Medtech GmbH FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection NAI · Dec 14, 2022
  • Last warning letter 2011
Inspections 2 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Aug 26, 2011
510(k) clearances 0 None on file

Dornier Medtech GmbH has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Dornier Medtech GmbH, the most recent on Aug 26, 2011.

What these totals cover: FDA records filed under the name "Dornier Medtech GmbH" and its spelling variant "Dornier Medtech".

Latest inspection
Dec 14, 2022 · NAI

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
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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Dornier Medtech GmbH FDA Warning Letters

1 warning letter on Aug 26, 2011.

IssuedSubjectIssuing officeClose-out letter
Aug 26, 2011 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

2 inspections from Apr 29, 2011 to Dec 14, 2022.

DateSiteProductClassificationFEI
Dec 14, 2022Wessling, GermanyDevicesNo Action Indicated (NAI)3002806833
Apr 29, 2011Wessling, GermanyDevicesOfficial Action Indicated (OAI)3002806833
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 Dornier Medtech GmbH: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Aug 26, 2011.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other 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 3002806833Wessling, Germany2Dec 14, 2022

Dornier Medtech GmbH and the FDA: common questions

Has Dornier Medtech GmbH received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Dornier Medtech GmbH. The most recent is dated Aug 26, 2011.

Has Dornier Medtech GmbH received an FDA Form 483?

FDA has not published a Form 483 for "Dornier Medtech GmbH" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Dornier Medtech GmbH?

The most recent FDA inspection on file ended Dec 14, 2022 at Wessling, Germany and was classified NAI. FDA has 2 inspections of Dornier Medtech GmbH on file, 1 of them classified OAI (official action indicated).

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