Green Hope LLC, which does business as Rosewood Products, and owner, Phi G. Ye, of Ann Arbor, Mich., have agreed to a consent decree of permanent injunction for violations of FDA food safety regulations. The consent decree was signed by Judge David M. Lawson of the U.S. District Court for the Eastern District of Michigan, Southern Division, on January 28, 2013.
Several FDA inspections found persistent violations involving insanitary conditions at the facility, leading to possible contamination of food. The firm manufactures and distributes organic tofu, soy milk and other products. (Warning Letter, May 6, 2011)
Under the consent decree, Green Hope must stop operations until the FDA approves the steps taken to bring its operations into full compliance with the Federal Food, Drug and Cosmetic Act and FDA food safety regulations. The steps include hiring an independent expert to develop a written sanitation control program and an employee training program, and assigning a Green Hope employee to implement and maintain the sanitation control program.
The FDA may at any time re-inspect the facility to ensure that these measures are being carried out. In addition, Green Hope will pay all costs of FDA supervision, inspections, analyses, examinations and reviews associated with this consent decree.
“Consumers expect their foods to be safe,” said Melinda K. Plaisier, acting associate commissioner for regulatory affairs. “When foods are not manufactured under sanitary conditions, those who prepare, process and distribute those foods should expect FDA enforcement action.”
No illnesses have been reported to date implicating Rosewood Products’ food. Illnesses or adverse events related to use of these products should be reported to the FDA.