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CLOSEOUT LETTER

Ortho Molecular Products Inc


Ortho Molecular Products Inc

  

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

 
 Food and Drug Administration
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7210
FAX: (612) 334-4142

December 10, 2014


Gary Powers
Owner/CEO
Ortho Molecular Products Inc.
1991 Duncan Place
Woodstock, Illinois 60098


Dear Mr. Powers:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter MIN 13-02 dated October 15, 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/

Demetria L. Lueneburg
Compliance Officer
Minneapolis District

 

DLL/ccl