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  5. Richard Wolf Medical Instruments Corp. - 06/04/2015
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Richard Wolf Medical Instruments Corp.

Richard Wolf Medical Instruments Corp.

United States

Issuing Office:

United States


Department of Health and Human Services' logoDepartment of Health and Human Services

Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863


June 4, 2015

Mr. Siegfried Karst
Chief Operating Officer
Richard Wolf, GmbH
Pforzheimer Straße 32
75438 Knittlingen

Dear Mr. Karst:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CHI-4-14, dated February 28, 2014. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.



Sandra K. Sylvester
Acting District Director

cc: Ms. Michele McDonald
      U.S. Head of Regulatory- QAIQC
      Richard Wolf Medical Instruments Corporation
      353 Corporate Woods Parkway
      Vernon Hills, Illinois 60061

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