The U.S. Food & Drug Administration (FDA) just announced that failur;09 e to correct violations prompted the agency to seek a court action against Chung’s Products LP. The U. S. Department of Justice, in an action initiated by the FDA, is seeking that permanent injunction against Chung’s Products LP; Charlie A. Kujawa, the company’s president; and Gregory S. Birdsell, the firm’s director of quality assurance. Chung’s Products is an egg roll manufacturer located in Houston, Texas.
The complaint, filed in the U.S. District Court for the Southern District of Texas, charges the defendants with violating the Federal Food, Drug, and Cosmetic Act by preparing, packing and holding shrimp egg rolls under <"https://www.yourlawyer.com/practice_areas/food_poisoning">unsanitary conditions, which could lead to the products becoming contaminated with filth and causing injury and danger to consumer health. The complaint concerns Chung’s fish and fishery products. It does not include Chung’s other food products. The shrimp egg rolls produced by Chung’s are sold in grocery stores and large retail stores nationwide.
“The agency has previously warned the company that corrective actions need to be taken in this facility,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “This FDA action is aimed at protecting the public health,” Chappell added.
FDA inspections have revealed significant deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) requirements, which are designed to protect the public from food safety hazards in fish and fishery products. Failure to comply with the seafood HACCP regulations renders food adulterated under the Act.
A 2009 FDA inspection of the firm showed significant deficiencies with the firm’s HACCP plan, including the continued failure to control for the risk of Clostridium botulinum (C. botulinum) toxin formation in its shrimp egg rolls that are packaged in modified atmospheric packaging at refrigerated temperatures.
Ingestion of C. botulinum toxin can cause botulism, a serious form of food poisoning that can cause life-threatening illness or death. Symptoms can include: General weakness, dizziness, double or blurred vision, drooping eyelids, slurred speech and trouble with speaking or swallowing, and dry mouth. Difficulty in breathing; weakness of other muscles—for instance, muscle weakness that starts at the shoulders and moves progressively down the body—abdominal distension, and constipation may also be common symptoms. Botulism poisoning can cause paralysis of breathing muscles, which can lead to death without treatment and respiratory ventilation in about eight percent of cases.
The 2009 inspection also found the presence of Listeria monocytogenes in the firm’s egg roll processing environment. Listeriosis, the food borne disease caused by the Listeria pathogen, is dangerous and can be deadly, causing serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer short-term symptoms, such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea. In pregnant women, Listeriosis can result in miscarriage, stillbirth, or birth of a baby suffering from the infection. Pregnant women are about 20 times likelier than others to be infected, with about one-third of all Listeriosis cases occurring during pregnancy. Listeriosis can kill fetuses, prompt premature births, and can lead to hearing loss or brain damage in newborns and neurological effects and cardio respiratory failure in adults.
