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CLOSEOUT LETTER

Sunergized LLC MARCS-CMS 548703 —

Recipient:
Sunergized LLC

United States

Issuing Office:

United States

 

   

Black HHS-Blue FDA Logo

 

 
 
5001 Campus Drive
College Park, MD 20740 

June 19, 2018

James Scarmozzino, Owner
Sunergized LLC
217 Woodbury Rd #84
Woodbury, NY 11797

Dear Mr. James Scarmozzino:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #548703, issued May 18, 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, MPH, RD
Acting 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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