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  5. Weifang Sunwoo Foods Co., Ltd. - Close Out Letter 10/26/16
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CLOSEOUT LETTER

Weifang Sunwoo Foods Co., Ltd.


Weifang Sunwoo Foods Co., Ltd.

  

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

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

October 26, 2016

Mr. Zhang Fengquan
General Manager and Owner
Weifang Sunwoo Foods Co., Ltd.
No. 1 Sunwoo Rd., Guanggong Town,
Amqui City (Weifang),
Shandong Province, China 262133

Dear Mr. Fengquan:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #454758, issued September 20, 2016. Based on our evaluation ofyour 7/30/15 response, your pickled radish product label contains the statement "Keep Refrigerated". If the product is kept under refrigeration after production and during storage and shipment, it would not be subject to the acidified food regulations (21 CFR 108 and 114). Accordingly, the deviations listed in the Warning Letter would not apply to your pickled sweet radish or to your other products, e.g., sweet ginger, seasoned burdock, if the product labels contained the statement "Keep Refrigerated" and the products were kept under refrigeration during storage and shipment. Future FDA inspections and regulatory activities will further assess your firm 's compliance with applicable regulations.

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/
Donald W. Greaves
Compliance Officer
Office of Compliance
Center for Food Safety
    and Applied Nutrition