Sunland Inc., the beleaguered manufacturer of peanut products, has entered into a consent decree to keep potentially harmful food from entering the market, the U.S. Food and Drug Administration (FDA) announced last week.
Invoking its powers under the two-year-old Food Safety Modernization Act, FDA last month suspended Sunland's registration after evidence linked the company to an outbreak of Salmonella Bredeney — a bacteria causing abdominal cramps, diarrhea and fever — that sickened 42 people in 20 states.
The consent decree signed by a federal judge in New Mexico paves the way for Sunland to reinstate operations after FDA effectively shut down its manufacturing business.
"However, the company cannot process or distribute food from its peanut butter plant or peanut mill plant in Portales, N.M., until it has complied with the consent decree’s requirements to the agency’s satisfaction," FDA cautioned in a press release Dec. 21. "Sunland must receive written authorization from the FDA prior to resuming operations at both its peanut butter and peanut mill plant."
Under the consent decree signed by U.S. District Judge William P. Johnson, Sunland must retain an independent sanitation expert to develop a sanitation control program, comply with cGMP regulations and conduct environment monitoring and testing of its peanut butter plant to verify disease-causing organisms are not present in the facility or its finished foods. The independent sanitation expert also must conduct comprehensive inspections of the facility, FDA said.
"Sunland's entire team is fully committed to continuing its work with FDA, its advisory team of experts and all agencies, to insure the manufacturing and distribution of safe, quality products," Sunland CEO Jimmie Shearer said in a press release Dec. 21.
The Salmonella Bredeney outbreak began in September 2012 and was traced back to peanut butter, nut butters and peanut butter products manufactured in its facility. An initial recall of food products was trigged Sept. 22, but has been expanded nearly 10 times to now include more than 100 brands and nearly 250 products.
