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CLOSEOUT LETTER

SK Food Group, Inc. Aug 13, 2018

SK Food Group, Inc. - Close Out Letter 8/13/18


Recipient:
SK Food Group, Inc.


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
1431 Harbor Bay Parkway
Alameda, CA 94502-7070 

August 13, 2018

Mr. Jakob Loseke,
Vice President for U. S. Operation and Plant Manager
SK Food Group, Inc.
5555 Quail Manor Court, Suite 100
Reno, NV 89511

CMS#515676

Dear Mr. Jakob Loseke:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 515676), dated March 13, 2017. 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/
Sergio Chavez, Director of Compliance
Office Human and Animal Foods
Division West 5