William H. Oshiro, owner of RZM Food Factory, has agreed to stop processing and distributing food until he demonstrates to the FDA that RZM Food Factory’s facility and practices comply with federal food safety requirements.
The agreement, known as a consent decree of permanent injunction, was signed by a federal judge and entered in the U.S. District Court of Hawaii on Dec. 11, 2014.
RZM Food Factory prepared, packed, and held ready-to-eat mung bean, alfalfa, radish and clover sprouts and distributed them in Hawaii. After FDA investigators documented unsanitary conditions at the firm during previous inspections, Mr. Oshiro had agreed to make changes in his production operation, but the FDA has repeatedly found and documented unsanitary conditions.
Sprouts are commonly consumed in their raw state without further processing to eliminate pathogens. Therefore, the manner in which they are produced, packed, and held is critical to ensuring that the potential for microbial contamination is minimized.
Mr. Oshiro has said that RZM Food Factory is no longer processing or distributing food. If Mr. Oshiro decides to resume operations, under the consent decree, he must first demonstrate that RZM Food Factory’s sanitary practices, building, and equipment are suitable to prevent contamination of the food that it prepares and distributes. In addition, to resume operations, Mr. Oshiro must, among other things, retain an independent sanitation expert and develop a program to eliminate unsanitary conditions at the facility.
“The FDA repeatedly advised RZM Food Factory of unsanitary conditions at the facility,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “If and when the company is permitted to resume operations, the FDA plans to continue monitoring its operations and may require the company to recall products or cease production if the agency discovers future violations of food safety practices.”
To date, the FDA has received no reports of illnesses associated with RZM Food Factory products. However, individuals who experience symptoms of foodborne illness after consuming food should contact their healthcare professional. Consumers are also encouraged to report problems with FDA-regulated products to their district office consumer complaint coordinator: http://www.fda.gov/safety/reportaproblem/consumercomplaintcoordinators/default.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.