Inspections, Compliance, Enforcement, and Criminal Investigations

Natural Alchemist - Close Out Letter 7/3/18

 

  

Black HHS-Blue FDA Logo

 

 

 
1431 Harbor Bay Parkway
Alameda, CA 94502-7070 

July 03, 2018

Mr. Will Claren, CEO
Natural Alchemist, Alurent Inc.
3941 Park Drive
El Dorado Hills, CA 95762

Dear Mr. Will Claren:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 513852), dated October 31, 2017. 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 action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/

Sergio Chavez, Director of Compliance
Office Human and Animal Foods
Division West 5
 

Page Last Updated: 07/09/2018
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