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CLOSEOUT LETTER

Tofu Yu, LLC Apr 17, 2017

Tofu Yu, LLC - Close Out Letter 4/17/17


Tofu Yu, LLC

 

  

Black HHS-Blue FDA Logo

 

 

 
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA, 94502
(510) 337-6700 

April 17, 2017

Our reference: CMS # 513233

Kevin E. Stong, Co-Owner/President
Tofu Yu, LLC
2618 8th Street
Berkeley, CA 94710-2514

Dear Mr. Stong:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, dated December 22, 2016. Based on our evaluation, it appears that 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.

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/

Lawton W. Lum
Director of Compliance
San Francisco District