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IEM Gmbh FDA Record

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

IEM Gmbh has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to IEM Gmbh, the most recent on Feb 24, 2012.

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

Latest inspection: Jan 24, 2013 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	3	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for IEM Gmbh above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
I.E.M	Same company group	0	5	0	0	—

IEM Gmbh FDA Warning Letters

1 warning letter on Feb 24, 2012.

Issued	Subject	Issuing office	Close-out letter
Feb 24, 2012 · 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

3 inspections from Feb 19, 2009 to Jan 24, 2013.

Date	Site	Product	Classification	FEI
Jan 24, 2013	Aachen, Germany	Devices	No Action Indicated (NAI)	1000628323
Oct 21, 2011	Aachen, Germany	Devices	Official Action Indicated (OAI)	1000628323
Feb 19, 2009	Aachen, Germany	Devices	Voluntary Action Indicated (VAI)	1000628323

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

Most recent: Warning Letter, Feb 24, 2012.

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 1000628323	Aachen, Germany	3	Jan 24, 2013

IEM Gmbh and the FDA: common questions

Has IEM Gmbh received an FDA warning letter?

Yes. FDA has issued 1 warning letter to IEM Gmbh. The most recent is dated Feb 24, 2012.

Has IEM Gmbh received an FDA Form 483?

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

When did the FDA last inspect IEM Gmbh?

The most recent FDA inspection on file ended Jan 24, 2013 at Aachen, Germany and was classified NAI. FDA has 3 inspections of IEM Gmbh on file, 1 of them classified OAI (official action indicated).

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