Inspections, Compliance, Enforcement, and Criminal Investigations

Zarbee's Naturals Inc. - Close Out Letter 3/13/18

 

  

Black HHS-Blue FDA Logo

 

 

 
6th Ave & Kipling St, DFC Bldg 20
PO Box 25087
Denver, CO 80225-0087
 

March 13, 2018

VIA UPS Overnight

Mr. Bret Furio, CEO
Zarbee's Inc.
50 Old Field Point Rd
Greenwich, CT 06830

Ref : DEN-14-09-WL

Dear Mr. Furio:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter DEN-14-09-WL, dated June 27, 2014. Based on our evaluation, it appears that you have addressed the violation(s) 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 actions should violations be observed during a subsequent inspection of through other means.
 

Sincerely,
/S/
LaTonya M. Mitchell
Denver District Director
Program Division Director
Office of Human and Animal Food - Division IV West 

Page Last Updated: 03/22/2018
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