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  5. Reproductive Medicine Institute IVF, LLC - Close Out Letter 11/7/14
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CLOSEOUT LETTER

Reproductive Medicine Institute IVF, LLC


Reproductive Medicine Institute IVF, LLC

  

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 7, 2014


Fernando L. Gomez, MD
President/Medical Director
Reproductive Medicine Institute IVF, LLC
258 S Chickasaw Trail, Ste 310
Orlando, FL 32825-3501


Dear Dr. Gomez:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [FLA-12-26, March 19, 2012]. 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/

Susan M. Turcovski
Director, Florida District