Green Hope Corrects FDA Food-Safety Alert

ANN ARBOR, Mich.Green Hope LLC is not required to shut down operations under a consent decree for violations of food-safety regulations, a lawyer for the company said Tuesday, contradicting a previous statement from the U.S. Food and Drug Administration (FDA).

Gary Peters, an attorney with Howard & Howard in Royal Oak, Mich., said FDA determined in October that Green Hope was in "full compliance with all applicable regulations".

The government agreed that as soon as the consent decree was filed FDA would issue a finding, stating the company was in full compliance with regulations and wouldn't be required to shut down operations, Peters said. Instead, FDA mistakenly issued a press release stating the company had agreed to cease operations, he said. FDA on Tuesday issued an amended relhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm337689.htmease.

In a Jan. 28, 2013, letter sent to Green Hope Owner Gary G. Ye, FDA confirmed the manufacturer of organic tofu and soy milk was complying with provisions of the consent decree "and all applicable FDA regulations."

"Therefore, you and Green Hope, LLC d/b/a Rosewood Products may continue receiving, processing, manufacturing, preparing, packing, holding, or distributing food at the facility located at 738 Airport Blvd., Suite 6, Ann Arbor, Michigan," Steven Barber, FDA's Director of Compliance with the Detroit District Office, wrote in the letter.

Barber warned Green Hope that FDA will continue to monitor its compliance with federal law and regulations and that the food safety agency could take action if the company violates the decree, FDA regulations or the Federal, Food, Drug and Cosmetic Act. FDA has the right under the consent decree to inspect Green Hope's facility in Ann Arbor or other locations without giving it prior notice.

"Those remedies include prohibiting you from selling any articles of food (paragraph 9), assessing liquidated damages (paragraph 11), and asking the Court to find you in civil or criminal contempt of the Decree," he wrote.

A federal judge, David M. Lawson, signed the consent decree last month after several FDA inspectors found that Green Hope a Michigan-based company doing business as Rosewood Products was operating a facility with unsanitary conditions, according to FDA. In a May 6, 2011 letter addressed to Ye, FDA warned the company it was violating Current Good Manufacturing Practices (CGMPs), potentially subjecting food to contamination.

"There was never any food that got into the stream of commerce that had got contaminated but I understand the rules," Peters said.

The consent decree imposed a number of requirements on Green Hope, including requiring the company to retain an independent expert to develop, and verify implementation of, a written sanitation program. Among other conditions, Green Hope was required to assign an employee to implement and monitor the program.