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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Ise Newberry, Inc. 13-Dec-05

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

Public Health Service
Food and Drug Administration

 

Atlanta District Office
60 8th Street, N.E.
Atlanta, GA 30309


December 13, 2005

VIA FEDERAL EXPRESS

Douglas C. Wicker, Vice President
Ise Newberry, Inc.
2060 Alexander Street
Newberry, SC 29108

Warning Letter
06-ATL-03

Dear Mr. Wicker:

In April 2005, public health officials in South Carolina's Department of Health and Environmental Control (DHEC) reported an outbreak of Salmonella serotype Enteritidis (SE). DHEC's investigation determined that the ill individuals ate at [redacted] Restaurant, [redacted] South Carolina, on April 16, 2005. DHEC found that macaroni and cheese served at [redacted] was statistically significantly related to consumers who became ill after eating at the restaurant. DHEC further concluded that a case control study and other information strongly suggest that shell eggs are the cause of the recent outbreak.

In June 2005, the Food and Drug Administration (FDA) conducted a traceback investigation on the macaroni and cheese served a [redacted] Restaurant. FDA's traceback investigation linked the April 2005 outbreak to shell eggs manufactured by your firm. Specifically, FDA believes that the most likely source for Salmonella serotype Enteritidis is the raw eggs used in the macaroni and cheese served at [redacted] and we believe that your firm is the most likely source for the macaroni and cheese's egg ingredient. Our investigation revealed that your Newberry, South Carolina facility manufactured and distributed eggs between March 24th and April 14 , 2005, to [redacted] of [redacted] who then distributed the eggs to [redacted] Restaurant. These eggs were used to prepare the macaroni and cheese. Therefore, we believe that the eggs that you supplied to [redacted] were adulterated within the meaning of Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act because the eggs were contaminated with the pathogenic bacteria Salmonella serotype Enteritidis, which may render the eggs injurious to health.

You should respond to this office in writing within fifteen (15) working days of receipt of this letter outlining the specific actions that you have and will take to prevent adulteration of eggs with SE and the shipment of adulterated eggs. If corrective and preventative actions can not be completed within fifteen working days, state the reason for the delay and the time within which corrections will be completed.

Your written response should be sent to the Food and Drug Administration, Compliance Branch, 60 Eighth St., NE, Atlanta, Georgia 30309 to the attention of Carlos A. Bonnin, Compliance Officer.

Sincerely,

/S/

Mary H. Woleske, Director
Atlanta District