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  5. U S Infusion, Inc. dba Truecare Biomedix-USA - Close Out Letter 11/10/15
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CLOSEOUT LETTER

U S Infusion, Inc. dba Truecare Biomedix-USA


U S Infusion, Inc. dba Truecare Biomedix-USA

  

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

 
 Food and Drug Administration
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
Fax: 407-475-4770

November 10, 2015

Marc I. Parness, President & CEO
US Infusion, Inc dba Truecare Biomedix-USA
6356 Manor Lane, Suite #103
South Miami, Florida 33143

Dear Mr. Parness:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [FLA-15-08, November 24, 2014]. 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/

Blake Bevill
Acting Director, Florida District