U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Tofu Yu, LLC - 04/17/2017
  1. Warning Letters


Tofu Yu, LLC

Tofu Yu, LLC

United States

Issuing Office:

United States



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.


Lawton W. Lum
Director of Compliance
San Francisco District

Back to Top