For Immediate Release: February 1, 2013
Media Inquiries: Pat El-Hinnawy, 301-796-4763, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
UPDATE: February 5, 2013. FDA has determined that Rosewood Products is operating in compliance with the Act and FDA food safety regulations, and on January 28, 2013, FDA notified Rosewood that it could continue receiving, processing, manufacturing, preparing, packing, holding or distributing food at its facility.
Michigan soy processor is under court order to meet FDA food safety standards
Multiple inspections found manufacturing violations and insanitary conditions
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.
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 at http://www.foodsafety.gov/report/index.html.
For more information:
Warning Letter, May 6, 2011
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.