Inspections, Compliance, Enforcement, and Criminal Investigations
Chung's Product, LP Response Letter
April 28, 2008
Via Electronic and US Mail
Carolyn Pinney, Compliance Officer
US Food and Drug Administration
4040 N. Central Expressway
Dallas, Texas 75204
Re: Chung's Products LP-October 30, 2008 Warning Letter
Dear Ms. Pinney:
This letter is to confirm that the open issues set out in the October 30, 2007 Warning Letter to Chung's Products, LP have all been fully discussed with the agency. We request the agency post this letter on FDA's web site linked to the Warning Letter.
As you know Chung's takes seriously its responsibilities under food law and regulation. From materials previously submitted, the exchange of communications that have been ongoing for some time, and the very helpful meeting at the agency earlier this month, the issues that have been discussed are as follows:
The Modified Atmosphere Packaging issues regarding Chung's products have been answered in accord with FDA Guidance based upon the confidential submissions made by Chung's. Going forward Chung's will continue to process and distribute the refrigerated MAP egg rolls that fall under FDA jurisdiction. The labeling to retailers has been changed to state that the temperature the retailer should maintain at all times after defrosting is a maximum of 40°F. Copies of this labeling have been previously provided to you.
The fryer temperature issues regarding Chung's products have been answered based upon Chung's heating the egg rolls to a temperature that is provided for in the confidential test Chung's submitted regarding heat distribution. Going forward Chung's will take into consideration the points made in the paper suggested by FDA that involves heat process for ready to eat cooked seafood. Chung's has acquired the paper.
The sanitation and water issues are all answered either by making corrections before the inspection was completed, by subsequently changing the procedures used during production to keep the water used clean and with the retraining of personnel in practices followed during processing to maintain the integrity of a clean production facility.
On behalf of Chung's I want to take this opportunity to thank you and your colleagues for the professional manner in which this matter has been handled.
Charles R. McConachie
CC: Chung's Foods
Mailing: PO Box 603022 Dallas. TX 75360
Physical: 1415 Halsey Way, Ste. 304 Carrollton, TX 75007 Office: 972.245.1600
www.mcconachielaw.com Fax: 972.245.1611