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Osmed Gmbh FDA Record

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

Latest inspection OAI · Jul 28, 2011
Last warning letter 2011

Inspections 1

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Nov 18, 2011

510(k) clearances 0 None on file

Osmed Gmbh has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Osmed Gmbh, the most recent on Nov 18, 2011.

What these totals cover: FDA records filed under the name "Osmed Gmbh" and its spelling variant "Osmed".

Latest inspection: Jul 28, 2011 · OAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	1	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Osmed Gmbh FDA Warning Letters

1 warning letter on Nov 18, 2011.

Issued	Subject	Issuing office	Close-out letter
Nov 18, 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

1 inspection on Jul 28, 2011.

Date	Site	Product	Classification	FEI
Jul 28, 2011	Ilmenau, Germany	Devices	Official Action Indicated (OAI)	3003507481

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 Osmed Gmbh: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Nov 18, 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.

Facility	Location	Inspections	Latest
FEI 3003507481	Ilmenau, Germany	1	Jul 28, 2011

Osmed Gmbh and the FDA: common questions

Has Osmed Gmbh received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Osmed Gmbh. The most recent is dated Nov 18, 2011.

Has Osmed Gmbh received an FDA Form 483?

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

When did the FDA last inspect Osmed Gmbh?

The most recent FDA inspection on file ended Jul 28, 2011 at Ilmenau, Germany and was classified OAI. FDA has 1 inspection of Osmed Gmbh on file, 1 of them classified OAI (official action indicated).

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