Failure to correct violations prompts FDA to seek court action against Chung’s Products LP
The U. S. Department of Justice, in an action initiated by the U.S. Food and Drug Administration, is seeking a permanent injunction against Chung’s Products LP ("Chung’s"), an egg roll manufacturer in Houston, Charlie A. Kujawa, the company’s president, and Gregory S. Birdsell, the firm’s director of quality assurance.
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 (the "Act") by preparing, packing and holding shrimp egg rolls under insanitary conditions, whereby they may have become contaminated with filth and rendered injurious to health. The complaint concerns Chung’s fish and fishery products. It does not include Chung’s other food products.
"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."
The shrimp egg rolls produced by Chung’s are sold in grocery stores and large retail stores nationwide.
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 potentially fatal disease. Although the incidence of botulism is very low, the disease can cause paralysis and has a high mortality rate if treatment is not prompt and appropriate.
The 2009 inspection also found the presence of Listeria monocytogenes ("L. mono") in the firm’s egg roll processing environment. L. mono can cause listeriosis, a disease that can be very serious, even fatal, for high-risk groups such as unborn babies, newborns, the elderly, and those with impaired immune systems.