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  5. Gate Gourmet Inc. - Close Out Letter 5/14/18
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CLOSEOUT LETTER

Gate Gourmet Inc. May 14, 2018

Gate Gourmet Inc. - Close Out Letter 5/14/18


Recipient:
Gate Gourmet Inc.


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772 

May 14, 2018

Dawn M. Sanchez, General Manager
Gate Gourmet, Inc.
3298 Lincoln Road Unit 117
Erlanger, Kentucky 41018

Dear Ms. Sanchez:

The Food and Drug Administration (FDA) completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 543440, where a "Provisional" status was given to your firm. Based on our re-inspection of your facility on April 24 and 26, 2018, it appears you have addressed the violations contained in this warning letter. Therefore, the classification is being changed to "Approved."

We acknowledge your response dated April 11, 2018, addressing corrective actions to the violations cited on the Form FDA 483, issued to you on April 26, 2018. Your corrective actions to the cited violations appear adequate. 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/
Kimberly A. Dutzek
Compliance Officer, Division V
Office of Human and Animal Foods Operations-East