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SANUM-Kehlbeck GmbH & Co. KG FDA Record

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

Latest inspection OAI · Mar 26, 2013
Last warning letter 2014

Inspections 1

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Apr 11, 2014

510(k) clearances 0 None on file

SANUM-Kehlbeck GmbH & Co. KG has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to SANUM-Kehlbeck GmbH & Co. KG, the most recent on Apr 11, 2014.

What these totals cover: FDA records filed under the name "SANUM-Kehlbeck GmbH & Co. KG" and its spelling variant "Sanum-Kehlbeck Gmbh And Co. Kg".

Latest inspection: Mar 26, 2013 · 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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SANUM-Kehlbeck GmbH & Co. KG FDA Warning Letters

1 warning letter on Apr 11, 2014.

Issued	Subject	Issuing office	Close-out letter
Apr 11, 2014 · 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 Mar 26, 2013.

Date	Site	Product	Classification	FEI
Mar 26, 2013	Hoya, Germany	Drugs	Official Action Indicated (OAI)	3002128313

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 SANUM-Kehlbeck GmbH & Co. KG: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Apr 11, 2014.

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 3002128313	Hoya, Germany	1	Mar 26, 2013

SANUM-Kehlbeck GmbH & Co. KG and the FDA: common questions

Has SANUM-Kehlbeck GmbH & Co. KG received an FDA warning letter?

Yes. FDA has issued 1 warning letter to SANUM-Kehlbeck GmbH & Co. KG. The most recent is dated Apr 11, 2014.

Has SANUM-Kehlbeck GmbH & Co. KG received an FDA Form 483?

FDA has not published a Form 483 for "SANUM-Kehlbeck GmbH & Co. KG" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect SANUM-Kehlbeck GmbH & Co. KG?

The most recent FDA inspection on file ended Mar 26, 2013 at Hoya, Germany and was classified OAI. FDA has 1 inspection of SANUM-Kehlbeck GmbH & Co. KG on file, 1 of them classified OAI (official action indicated).

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