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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Stryker Instruments Div. of Stryker Corporation - Close Out Letter 1/14/14

  

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

Public Health Service
 Food and Drug Administration
Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139

 

January 14, 2014


VIA UPS


Mr. Kevin Lobo
President and CEO
Stryker Corporation
2825 Airview Boulevard
Kalamazoo, MI 49002


Dear Mr. Lobo:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter issued to Stryker Instruments Division of Stryker Corporation located in Portage, Michigan [Warning Letter #2013-DET-07, dated March 6, 2013]. 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/

Catherine V. Quinlan
Compliance Officer
Detroit District


Individual Copy sent by UPS to:
Mr. James N. Heath, President
Stryker Instruments
4100 E. Milham Avenue
Kalamazoo, MI 49001