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CLOSEOUT LETTER

Purevive Health Sciences, LLC


Recipient:
Purevive Health Sciences, LLC


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild, Irvine, CA 92612
Telephone: 949-608-4496 

UNITED PARCEL SERVICE
SIGNATURE REQUIRED

June 14, 2018

Carmen P. Bickell, Owner
Pure Vive Health Sciences, LLC formerly Vitalife, Inc. dba Tabak's Health Products
11258 Monarch St., Ste. L
Garden Grove, CA 92841

RE: WL #33-16 Close-Out Letter

Dear Ms. Bickell:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #33-16, dated June 20, 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 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/

Sergio Chavez
Director Compliance Branch
Food and Drug Administration
HAF Division West 5