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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Victus, Inc. Close Out Letter 10/7/10

   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  555 Winderley Pl., Ste. 200
Maitland, Fl 32751 

October 7, 2010


Enrique J. Lopez
President
Victus, Inc.
4918 SW 74th Ct
Miami, FL 33155-4400


Dear Mr. Lopez:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [FLA-10-06, December 21, 2009]. 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/
Emma R. Singleton
Director, Florida District