U.S. organic soy processing firm Green Hope LLC has agreed to a consent decree of permanent injunction after several inspections by regulators found food safety violations at its plant.
The consent decree was issued to Green Hope, which trades as Rosewood Products, and owner Phi G. Ye, of Ann Arbor, Michigan, by Judge David M. Lawson of the U.S. District Court for the Eastern District of Michigan, Southern Division. The court order was signed on Jan. 28, 2013, the U.S. Food and Drug Administration (FDA) said.
Multiple inspections by the FDA found that the company was persistently violating sanitary requirements at its facility, leading to potential contamination of its food products. Green Hope manufactures and distributes ready-to-eat (RTE) organic tofu, soy milk and other products to companies in Michigan and Minnesota.
Specifically, the FDA inspections found that the firm did not store the food properly, did not address employee cleanliness issues, allowed waste water to come in contact with tofu during processing and failed to clean all food-contact surfaces and equipment. The violations involving insanitary conditions included company employees touching tofu with bare, uncovered arms. One worker was found to use his mouth to siphon liquid through a plastic hose from a kettle with ready-to-eat tofu in it. The company was sent a warning letter on May 6, 2011 informing it of the serious violations found by the FDA inspectors. No illnesses associated with the use of Green Hope's products have been reported to date.
The firm must now halt operations until the FDA approves the measures taken to bring its operations into full conformity with the food safety regulations of the FDA and the Federal Food, Drug and Cosmetic Act. Green Hope must hire an independent expert to prepare a written sanitation control program and staff training program. Another step for regaining full compliance with the food safety requirements includes assigning a company employee to conduct and maintain the sanitation control program. Green Hope is further required to make structural repairs to its facility to protect against contamination of input materials, in-process and finished foods, packaging materials and containers.
The FDA may make additional inspections at the facility at any time to ensure the steps are being implemented. The company is also required to cover all costs related to the inspections, supervision, examinations, analyses and reviews carried out by the FDA in relation to this consent decree.
Companies that prepare, process and distribute foods must follow strict sanitary requirements to ensure their products do not jeopardize public health. Food companies that breach food safety regulations should expect FDA enforcement action, said Melinda K. Plaisier, acting associate commissioner for regulatory affairs.