On April 27, 2016, the United States District Court for the Northern District of California entered a consent decree of permanent injunction against Kun Wo Food Products Inc., located in San Francisco, and its co-owners, Zi Xing Liu and Zi Chen Liu (“Kun Wo”), after the U.S. Food and Drug Administration documented violations of federal food safety laws. The U.S. Department of Justice handled the case on behalf of the FDA.
According to the complaint filed with the consent decree, FDA inspections at Kun Wo in 2015 and 2016 found unsanitary conditions in which noodles may have become contaminated. Listeria monocytogenes (L.mono) was found in the environment, and the company’s rice noodles were also at risk of contamination from Bacillus cereus, Salmonella, Escherichia coli, and Staphylococcus aureus. L. mono is a bacterium that can cause serious illness or even death in vulnerable groups including elderly adults and those with impaired immune systems (such as HIV/AIDS, cancer, diabetes, kidney disease and transplant patients). In pregnant women, listeriosis can cause miscarriage, stillbirth, premature labor, and serious illness or death in newborn babies. The FDA investigators observed that company allowed employees to touch food without cleaning their hands after handling dirty machinery and equipment. The company also failed to take adequate measures to protect food against the risk of contamination from other sources, including pests and condensation.
“The FDA has an obligation to protect public health, and we will take action when we see a company repeatedly violating food safety regulations,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs.
After the FDA’s 2015 inspection, Kun Wo made inadequate and unsuccessful corrections to its processes and facility issues. The FDA conducted an additional inspection in 2016 and found continuing and ongoing violations of current Good Manufacturing Practice regulations.
As a result of this court action, Kun Wo was ordered to cease processing and distributing food. Under the consent decree, if Kun Wo intends to resume operations, it must give the FDA at least 90 days’ advance notice and fulfill other requirements before the company can begin operating. Kun Wo must, among other things, retain an independent expert to develop a pathogen control program, retain an independent laboratory to conduct analyses of both the environment and food products, and provide employee training on sanitary food handling techniques. If Kun Wo is permitted to resume operations, the consent decree requires the company to obtain independent audits to ensure ongoing compliance.