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  5. Chaotic Labz - Close Out Letter 9/11/18
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Chaotic Labz


Recipient:
Chaotic Labz


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740

September 11, 2018

Cordy Hooten
Chaotic Labz
220 Hankins Drive
Atkins, AR 72823

Dear Mr. Hooten:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter Re: 491536, issued March 31, 2016. Based on our evaluation, it appears you have addressed the violation(s) contained in the 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/

Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition