U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Tribravus Enterprises, LLC - Close Out Letter 6/27/18
  1. Warning Letters

CLOSEOUT LETTER

Tribravus Enterprises, LLC


Recipient:
Tribravus Enterprises, LLC


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740 

June 27, 2018
 

Mr. David Nelson
Tribravus Enterprises, LLC dba iForce Nutrition
1305 Hot Spring Way #103
Vista, CA 92081

1330 Specialty Drive, Suite A
Vista, CA 92081

Dear Mr. Nelson:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 456725, issued April 22, 2015. Based on our evaluation, it appears you have addressed the violations 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
Acting Branch Chief
Dietary Supplements and Labeling
      Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition