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. Choice Detox Center, Inc. dba Nofeel - 543456 - 09/11/2018
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Choice Detox Center, Inc. dba Nofeel MARCS-CMS 543456 — Sep 11, 2018

Choice Detox Center, Inc. dba Nofeel - 543456 - 09/11/2018

Product:
Drugs

Recipient:
Recipient Name
Mr. Kenneth Nersten
Choice Detox Center, Inc. dba Nofeel
Choice Detox Center, Inc. dba Nofeel

552 Hamilton Street
Suite E-1
Costa Mesa, CA 92627
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

5001 Campus Drive
College Park, MD 20740
United States


September 11, 2018

 

Dear Mr. Nersten:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 543456, issued January 11, 2018. 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 Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement Office of Compliance
Center for Food Safety and Applied Nutrition