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CLOSEOUT LETTER

Miami Fat Supply, Inc Jan 19, 2018

Miami Fat Supply, Inc - Close Out Letter 1/19/18


Recipient:
Miami Fat Supply, Inc


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

Florida District Office
555 Winderley Place #200
Maitland, FL 32751
Telephone: (407) 475-4700

 
 

VIA ELECTRONIC MAIL

mark@miamifatsupply.com

January 19, 2018

Mr. D. Mark Jordan, President
Miami Fat Supply, Inc.
1510 Max Hooks Road, #F
Groveland, Florida 34736 U.S.A.

RE: Warning Letter Close-Out Letter – FEI 3008872140
      CMS Case ID: 485740, CMS WA ID: 182270

Dear Mr. Jordan:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter FLA-16-12, dated March 17, 2016. 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/

Kathleen M. Sinninger
Acting Program Division Director
Division of Medical Devices and
Radiological Health Operations II Central