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CLOSEOUT LETTER

Strictly Health Corp


Strictly Health Corp

 

  

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740

JUL 13, 2017
 

Anna McLean
Strictly Health Corporation
795 Commerce Drive UNIT 1
Venice, FL 34292

Anna McLean
Strictly Health Corporation
8437 Tuttle Ave #403
Sarasota, FL 34243

Dear Ms. Anna McLean:

The Food and Drug Administration (FDA) has completed an evaluation of your firm 's corrective actions in response to our Warning Letter #448808, issued May 7, 2015. 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 orwith 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/

Latasha A. Robinson, M.S.
Branch Chief
Dietary Supplements & Labeling
     Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety
     and Applied Nutrition