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  5. Brookfield Prescription Center Inc. dba MD Custom Rx - Close Out Letter 1/11/16
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CLOSEOUT LETTER

Brookfield Prescription Center Inc. dba MD Custom Rx


Brookfield Prescription Center Inc. dba MD Custom Rx

  

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

 
 Public Health Service
Food and Drug Administration
Minneapolis District
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone (612) 334-4100
Fax          (612) 334-4142

January 11, 2016

Monica M. Zatarski, PharmD, RPh, President/Co-owner
Brookfield Prescription Center, Inc. dba MD Custom Rx
19035 W. Capitol Dr., Suite 102
Brookfield, WI 53045

Dear Ms. Zatarski:

The U.S. Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our warning letter (ref: WL# MIN 14-19) dated May 2, 2014. 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 Lueneburg
Compliance Officer
Minneapolis District