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  5. CV7 Holdings LLC - 552109 - 02/15/2019
  1. Warning Letters

CLOSEOUT LETTER

CV7 Holdings LLC MARCS-CMS 552109 —

Product:
Dietary Supplements
Recipient:
Recipient Name
Amanda Sotta
Recipient Title
Manager
CV7 Holdings LLC

1818 SW 1st Street
Miami, FL 33129
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

Dear Ms. Sotta:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #552109, 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
Branch Chief
Dietary Supplement and Labeling Compliance Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition

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