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U.S. Department of Health and Human Services

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Enforcement Actions

Mirrotek International, LLC - Close Out Letter 8/20/12

  

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

Public Health Service
Food and Drug Administration
 

Central Region
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054 

Telephone (973) 331-4902

August 20, 2012

Mr. Joseph Bezborodko, President
Mirrotek International, LLC
90 Dayton Ave, Suite 1 F
Passaic, NJ 07055-7014

Dear Mr: Bezborodko:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 12-NWJ-11, dated February 9, 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/

CAPT Joseph F. McGinnis
Director, Compliance Branch
New Jersey District