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CLOSEOUT LETTER

Mark Northcutt Apr 26, 2018

Mark Northcutt - Close Out Letter 4/26/18


Mark Northcutt

 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Human and Animal Food –
West Division II
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100

April 26, 2018

DELIVERY VIA UPS
WARNING LETTER CLOSE-OUT LETTER

Mark Northcutt, Owner
33436 Highway 19
Laddonia, MO 63352

Dear Mr. Northcutt:

The Food and Drug Administration has completed an evaluation of Mark Northcutt corrective actions in response to our Warning Letter (CMS case #: 501198) on July 22, 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/

Miguel A. Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West