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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Scottcare Corporation - Close Out Letter 8/13/12

  

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) 679-2771
 

August 13, 2012

Kenneth M Zajaczkowski
Vice President/General Manager
Scottcare Corporation
4791 W 150th Street
Cleveland, OH 44135-3301

Dear Mr. Zajaczkowski:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #CIN-12-278457-12 dated February 21, 2012. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Further FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your 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/

Toniette K. Williams
Director, Compliance Branch
District Director
Cincinnati District