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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Christian Hospital Northeast-Northwest - Close Out Letter 5/7/12

  

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

May 7, 2012

Ronald B. McMullen, President
Christian Hospital Northeast-Northwest
11133 Dunn Road
St. Louis, Missouri 63136

Dear Mr. McMullen:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter CBER -12-02 dated March 27, 2012. 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.

Sincerely,

/s/


Mary A. Malarkey, Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research


cc:

    John Thorsky, District Director
    Kansas District, HFR- SW 300
    Food and Drug Administration
   11510 West 80th Street
   Lenexa, Kansas 66214