FDA USDA New Authority for First Time
The Food Institute this week reports that FDA suspended the food facility registration of peanut butter manufacturer Sunland, Inc. preventing it from producing or distributing any food into interstate or intrastate commerce, marking FDA’s first such move under the new Food Safety Modernization Act, which allows the agency to suspend registration when food manufactured or held at a facility has a “reasonable probability of causing serious adverse health consequences or death to humans or animals.” The agency reported its decision was based on an outbreak of Salmonella Bredeney linked to the company’s peanut butter that sickened 41 people in 20 states and a history of violations at Sunland’s Portales, NM plant. FDA will reinstate the company’s registration only when the agency determines that the company has implemented procedures to produce safe products.
FDA’s review of Sunland’s product testing records revealed 11 product lots of nut butter showed the presence of Salmonella between June 2009 and September 2012, and between March 2010 and September 2012 at least a portion of eight product lots of nut butter that Sunland’s own testing program identified as containing Salmonella was distributed by the company to consumers. During FDA’s inspection of the plant, performed from Sept. 17 to Oct. 16, the agency also found the presence of Salmonella in 28 environmental samples .
A Nov. 26 letter to Sunland concerning the food facility registration suspension listed a number of Current Good Manufacturing Practice (CGMP) Violations, which rendered the firm’s ready-to-eat nut butter and nut products to be adulterated within the meaning of the Food Drug and Cosmetics Act, in that the foods have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Specifically, investigators observed a number of conditions and practices likely to result in cross-contamination between raw peanuts and peanuts that have been roasted or brined, as raw peanuts are more likely to contain pathogenic bacteria, particularly Salmonella. Packaging equipment was reportedly not effectively cleaned to prevent contamination between raw and roasted peanuts, collapsible mesh totes used to store and transport nuts around the facility carried raw peanuts, roasted and/or brined peanuts and peanut food waste without being cleaned and sanitized between uses.
The plant’s nut building was also found to not have any hand washing sinks in the production or packaging areas, essential in preventing cross-contamination, while another sink was observed leaking with water accumulating onto the floor.
A written response to was sent by Sunland and received by FDA Nov. 9. According to FDA, however, the response omitted “significant details regarding planned physical repairs and corrective actions, and the adequacy or effectiveness of these corrective actions cannot be determined based on the information provided in the response.” Until FDA concludes Sunland has completed and implemented certain corrective actions, food manufactured, processed, packed, received or held by Sunland has a reasonable probability of causing serious adverse health consequences or death to humans or animals and will be restricted from entering commerce.