Moeller Medical GmbH FDA Record

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

  • Latest inspection VAI · Mar 30, 2023
  • No warning letters matched by name
Inspections 2 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Moeller Medical GmbH has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Moeller Medical GmbH" is on file.

What these totals cover: FDA records filed under the name "Moeller Medical GmbH" and its spelling variant "Moeller Medical". Records filed under related names are not included; see Related names.

Latest inspection
Mar 30, 2023 · VAI

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 actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

2 inspections from Jan 30, 2014 to Mar 30, 2023.

DateSiteProductClassificationFEI
Mar 30, 2023Fulda, GermanyDevicesVoluntary Action Indicated (VAI)3002807634
Jan 30, 2014Fulda, GermanyDevicesVoluntary Action Indicated (VAI)3002807634
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.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002807634Fulda, Germany2Mar 30, 2023

Moeller Medical GmbH and the FDA: common questions

Has Moeller Medical GmbH received an FDA warning letter?

No FDA warning letter addressed to the name "Moeller Medical GmbH" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Moeller Medical GmbH received an FDA Form 483?

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

When did the FDA last inspect Moeller Medical GmbH?

The most recent FDA inspection on file ended Mar 30, 2023 at Fulda, Germany and was classified VAI. FDA has 2 inspections of Moeller Medical GmbH on file.

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