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  1. Compliance Actions and Activities

CLOSEOUT LETTER

Well Luck Co. Inc. Sep 01, 2015

Well Luck Co. Inc. - Close Out Letter 9/1/15


Well Luck Co. Inc.

  

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

Food and Drug Administration
Atlanta District Office
 60 8th St., NE
Atlanta, GA 30309

VIA UNITED PARCEL SERVICE

September 1, 2015

Chris T. Li, CEO/Owner
Well Luck Company, Inc.
104 Harbor Drive
Jersey City, NJ 07305

Dear Mr. Li:

On July 23, 2014 thru August 7, 2014 the U.S. Food & Drug Administration (FDA) conducted an inspection of your food manufacturing and storage facility located at 1585 Market Drive, SE, Atlanta, GA. Following that inspection you received a Warning Letter [WL # 14-ATL-12 dated 9/17/14]. On March 31, 2015, we completed an evaluation of your firm's corrective actions in response to our Warning Letter. 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/

Janice L. King, Compliance Officer
Atlanta District
Janice.king@fda.hhs.gov
843-746-2990, x16


cc: Khong H. Khoo, General Manager
     Well Luck Company, Inc.
     1585 Market Dr., SE
     Atlanta, GA 30316-4718