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  5. Soothedrawal, Inc. - 543430 - 09/11/2018
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CLOSEOUT LETTER

Soothedrawal, Inc. MARCS-CMS 543430 —

Recipient:
Soothedrawal, Inc.

United States

Issuing Office:

United States

 

   

Black HHS-Blue FDA Logo

 

 
 
5001 Campus Drive
College Park, MD 20740 

September 11, 2018

Soothedrawal, Inc.
Attn: David McDonald
Attn: Terrie McDonald
3330 Cobb Pkwy NW
Suite 324
Acworth, GA 30101

Dear Mr. and Ms. McDonald:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 543430, 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 

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