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CLOSEOUT LETTER

VitalHealth Tech Inc. May 21, 2015

VitalHealth Tech Inc. - Close Out Letter 5/21/15


VitalHealth Tech Inc.

  

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

Public Health Service
Central Region
 Food and Drug Administration
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054

 

Telephone (973) 331-4902


 

May 21, 2015


Mr. Mukesh D. Solanki, President
VitalHealth Tech Inc.
1 Carol Street
Clifton, New Jersey 07014


Dear Mr Solanki:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter, file number 15-NWJ-02. 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