FDA NEWS RELEASE
For Immediate Release: Dec. 22, 2011
Media Inquiries: Doug Karas, 301-796-2805, email@example.com
Consumer Inquiries: 1-888-INFO-FDA
FDA: Chicago-area sandwich manufacturer agrees to stop production
Action prompted by conditions favorable to Listeria growth, history of violations
The U.S. Food and Drug Administration announced today that a Chicago-area company has agreed to stop making its ready-to-eat sandwiches and produce after FDA investigators repeatedly found unsanitary conditions and bacterial contamination in the facility.
The company, Triple A Services Inc., and its owners and operators, Thomas J. Whennen, Scott C. Whennen and David A. Frisco, have agreed to stop producing and distributing the sandwiches and produce as part of a consent decree filed in the U.S. District Court of the Northern District of Illinois.
The terms of the decree would also require Triple A to hire a sanitation expert to help establish an effective sanitation program, to comply with FDA regulations and to eliminate Listeria contamination from company facilities.
The government’s complaint, filed by the U.S. Department of Justice on December 22, 2011, describes Triple A’s history of operating under unsanitary conditions and Listeria monocytogenes contamination in the processing facility. It also outlines Triple A’s failure to comply with Current Good Manufacturing Practice and seafood Hazard Analysis and Critical Control Point regulations.
Listeriosis, the illness caused by Listeria monocytogenes, can be serious and sometimes causes fatal infections in young children, older people, and in those with weakened immune systems. Healthy people may experience short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea. Listeriosis can also cause miscarriages and stillbirths.
“FDA took these aggressive actions because Triple A Services continued to violate current good manufacturing practice regulations and allow for conditions that could affect the health of consumers,” said Dara Corrigan, the FDA’s associate commissioner for regulatory affairs.
No illnesses have been reported to date from Triple A Services’ products. Illnesses or adverse events related to use of these products should be reported to the FDA at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation and for regulating tobacco products.
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