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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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ThyssenKrupp Access Manufacturing, LLC - Close Out Letter 11/29/2012

  

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

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

November 29,2012

VIA UPS NEXT DAY

 

Mr. Jurrien Vander Akker
President
ThyssenKrupp Access Manufacturing, LLC
4001 E. 138th Street
Grandview, Missouri 64030


Dear Mr. Vander Akker:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CHI-2-12, dated March 27, 2012. Based on our evaluation, it appears that you have addressed the violation(s) 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.


Sincerely,

/S/

Scott J. Maclntire
District Director


CC: Mr. Kevin Brinkman
      Vice President of Engineering and Quality
      ThyssenKrupp Access Manufacturing, LLC
      509 W. Front Street
      Roanoke, Illinois 61561