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CLOSEOUT LETTER

Florida Fertility Institute, P.A. Aug 21, 2014

Florida Fertility Institute, P.A. - Close Out Letter 8/21/14


Florida Fertility Institute, P.A.

  

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

 

August 21, 2014


Mark D. Sanchez, M.D.
IVF Director
Florida Fertility Institute, P.A.
2454 N. McMullen Booth Road, Suite 601
Clearwater, FL 33759


Dear Dr. Sanchez:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [FLA-14-01, December 12, 2013]. 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/

Elizabeth W. Ormond
Acting Director, Florida District