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CLOSEOUT LETTER

T. Ho Foods, Inc. 16/05/2016

T. Ho Foods, Inc. - Close Out Letter 5/16/16


T. Ho Foods, Inc.

  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 - Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
         FAX: (615) 366-7802

May 16, 2016
 

Thuc G. Ho and Thoai Ho, Co-Owners
T-Ho Foods
7124 Small Creek Way
Powell, Tennessee 37849-4850

Dear Messrs. Ho:

The Food and Drug Administration (FDA) completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 2015-NOL-12, dated July 22, 2015. Based on our evaluation, it appears you have addressed the violations contained in this warning letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

During the FDA inspection on March 2, 2016, several cases of canned crabmeat were observed stored in the refrigerator. This is to inform you, any seafood product ingredients, which are intended for long term storage at refrigerated temperatures (as opposed to receiving product·frozen and stored in the walk-in cooler to thaw), should be included on the Hazard Analysis Critical Control Point (HACCP) plan and the temperature of the cooler should be monitored at sufficient frequency to prevent temperature abuse and subsequent potential contamination of the product.

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 L. McMillan
Acting Compliance Branch Director
New Orleans District