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Karl Storz GMBH & Co KG (KSVEM) FDA Record

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

Latest inspection VAI · Nov 28, 2012
Last warning letter 2010

Inspections 2

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Feb 23, 2010

510(k) clearances 0 None on file

Karl Storz GMBH & Co KG (KSVEM) has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Karl Storz GMBH & Co KG (KSVEM), the most recent on Feb 23, 2010.

What these totals cover: FDA records filed under the name "Karl Storz GMBH & Co KG (KSVEM)" and its spelling variant "Karl Storz Gmbh And Co Kg (Ksvem)".

Latest inspection: Nov 28, 2012 · VAI

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	2	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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Karl Storz GMBH & Co KG (KSVEM) FDA Warning Letters

1 warning letter on Feb 23, 2010.

Issued	Subject	Issuing office	Close-out letter
Feb 23, 2010 · 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 Oct 29, 2009 to Nov 28, 2012.

Date	Site	Product	Classification	FEI
Nov 28, 2012	Garching-Hochbruck, Germany	Devices	Voluntary Action Indicated (VAI)	3006453991
Oct 29, 2009	Garching-Hochbruck, Germany	Devices	Official Action Indicated (OAI)	3006453991

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 Karl Storz GMBH & Co KG (KSVEM): warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Feb 23, 2010.

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 3006453991	Garching-Hochbruck, Germany	2	Nov 28, 2012

Karl Storz GMBH & Co KG (KSVEM) and the FDA: common questions

Has Karl Storz GMBH & Co KG (KSVEM) received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Karl Storz GMBH & Co KG (KSVEM). The most recent is dated Feb 23, 2010.

Has Karl Storz GMBH & Co KG (KSVEM) received an FDA Form 483?

FDA has not published a Form 483 for "Karl Storz GMBH & Co KG (KSVEM)" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Karl Storz GMBH & Co KG (KSVEM)?

The most recent FDA inspection on file ended Nov 28, 2012 at Garching-Hochbruck, Germany and was classified VAI. FDA has 2 inspections of Karl Storz GMBH & Co KG (KSVEM) on file, 1 of them classified OAI (official action indicated).

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