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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Derek and Constance Lee Corporation, d.b.a. Great River Foods - Close Out Letter 4/8/14

  

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

Food and Drug Administration
San Francisco District
 1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: (510) 337-6700
FAX: (510) 337-6707

 

VIA CERTIFIED MAIL


April 8, 2014


Mr. Derek L. Lee, President
Derek and Constance Lee Corporation
d.b.a. Great River Food
14500 East Valley Boulevard
City of Industry, CA 91746


Dear Mr. Lee:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated November 16, 2012, and our reference case number CMS 376558. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. An FDA Investigator verified your corrections during an inspection of your facility conducted February 18-21, 2014. The remainder of your corrections were verified after our review of your response to the FDA 483, dated February 21, 2014. 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, Compliance Branch
San Francisco District

 


Cc: Fong Lee, District Manager
      Derek and Constance Lee Corporation, d.b.a. Great River Foods
      1082 Revere Ave. San Francisco, CA 94124