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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Nemechek Do Pa Close Out

 

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

Public Health Service
Food and Drug Administration
 Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448


July 29, 2010

Patrick M. Nemechek, D.O.
3601 West 63rd Street
Mission Hills, Kansas 66208

Dear Dr. Nemechek:

The Food and Drug Administration has completed an evaluation of your undated letter in response to the Food and Drug Administration's Warning Letter CBER-10-06 dated June 28, 2010. 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/
Mary A. Malarkey, Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

cc: John Thorsky, Director
Kansas City District Office
Food and Drug Administration
11510 West 80th Street
Lenexa, Kansas 66214-3340

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