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CLOSEOUT LETTER

VitaCare Pharma, LLC


Recipient:
VitaCare Pharma, LLC


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455 

 
 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

September 15, 2017
 

Dr. Manav Shah
President and CEO
VitaCare Pharma LLC
111 Skyline Drive
South Plainfiled, NJ 07080

Dear Dr. Shah:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 16-NWJ-04 issued March 7, 2016. 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 wit 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/

Randy F. Pack
Director of Compliance Branch
Human and Animal Food East, Division 2