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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Southern Foods Group LLC Response Letter

December 1, 2009

 

 

 

Food and Drug Administration
Attn: District Director
Atlanta District Office
60 Eighth Street, NE
Atlanta, GA 30309

 

Dear District Director:

This letter is written in response to your warning letter (09-ATL-04) dated 21 May 2009 concerning FDA Inspection (FDA 483) ON 12-16 Jan. 2009.

Southern Foods Group LLC understands your concerns and respects your comments and suggestions. We realize the necessity of your concerns and have incorporated your suggestions into our Southern Foods HAACP plan.

Since your initial visit, we have added (b)(4) HAACP trained AFDO Certified associates in our Seafood Division. We immediately corrected the the Facility-Sanitation related concerns that FDA 483 Inspectional Report contained. We are now documenting our existing quarterly vertification of (b)(4) content in our Smoked Fish HAACP Plan that is tested through a FDA certified laboratory, as well as documenting our quarterly GMP meetings.

In addition, we sought the direction of (b)(4) for guidance. (b)(4) toured and analyzed our facility providing suggestions and recommendations to further improve our HACCP plan. Our HACCP plan was then amended to include (b)(4) expert evaluation. (b)(4) also guided us with the amendments to the four HAACP plans addressed in FDA 483 Inspectional Report dated 16 Jan. 2009. All observations noted during this inspection were completed in a timely manner, some of which were completed during the inspection. All of the amendments to the four Seafood HAACP plans related to FDA 483 Report dated 12-16 Jan. 2009 were sent to your Atlanta office for approval.

We respect that HAACP is a necessary food safety system and assure you that Southern Foods Group LLC is committed to producing only high quality, safe products.

Sincerely.

/s/

Michael McQuade
VP of Production