Inspections, Compliance, Enforcement, and Criminal Investigations

Intensive Nutrition Incorporated - Close Out Letter 10/9/18

  

Department of Health and Human Services logo

 
 
U.S. Food & Drug Administration
OHAFO West Division 5
1431 Harbor Bay Parkway
Alameda, CA 94502

 
October 9, 2018

Olivia B. Melaugh, President
Intensive Nutrition, Inc.
1972 Republic Ave.
San Leandro, CA 94577-4224

RE: WL Close-Out Letter

Dear Ms. Melaugh:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, dated January 22, 2014. 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

Page Last Updated: 10/15/2018
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