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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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Regional Medical Center - Close Out Letter 12/21/11

  

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

Public Health Service
Food and Drug Administration
 

Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761

December 20, 2011

Dr. Justin B. Sedlak, Laboratory Medical Director
Regional Medical Center
900 Hospital Drive
Madisonville, Kentucky

Dear Dr. Sedlak:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #CIN-11-174032-13, dated April 21, 2011. 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 you or your firm 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 of through other means.

Sincerely,

/S/

Toniette K. Williams
Compliance Director
Cincinnati District
 

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