FDA suspends Sunland manufacturing facility registration
The U.S. Food and Drug Administration (FDA) utilized the Food Safety Modernization Act (FSMA) for the first time in its suspension of Sunland Inc.’s food facility registration Nov. 26. The manufacturer of nuts and nut and seed spreads is linked to an outbreak of Salmonella bredeney that sickened 41 people in 20 states and included recalls of Dogsbutter Brand All Natural Jarred Peanut Butter Treat for Dogs, among numerous other peanut butter products. The recent outbreak and a history of violations at the Sunland facility in Portales, N.M., led the FDA to suspend registration.
Registration is required for any facility that manufactures, processes, packs or holds food for consumption in the United States, according to the FDA. The suspension prohibits Sunland from allowing its nut products to enter into commerce. The FSMA, signed into law Jan. 4, 2011, aimed to change the FDA’s focus from responding to contamination to preventing contamination in the United States food supply.
During an inspection of the Sunland Inc. facility conducted this fall, the FDA found that between June 2009 and August 2012, Sunland had distributed or cleared portions of daily production runs of peanut or almond butter after internal testing identified the presence of at least one of nine different Salmonella species (arapahoe, bredeney, cerro, dallgow, kubacha, mbandaka, meleagridis, newport and teddington) in those lots. Two of these lots showed the presence of Salmonella bredeney, the FDA says. The FDA’s call for corrective action prompted Sunland to expand its ongoing recall.
In addition, FDA investigators found that employees had improperly handled equipment, containers and utensils used to hold and store food. “There were no hand washing sinks in the peanut processing building production or packaging areas and employees had bare-handed contact with ready-to-package peanuts,” the release says. There were no records documenting the cleaning of production equipment. Investigators also found that raw materials had been exposed to potential contamination. “Raw, in-shell peanuts were found outside the plant in uncovered trailers. Birds were observed landing in the trailers and the peanuts were exposed to rain, which provides a growth environment for Salmonella and other bacteria. Inside the warehouse, facility doors were open to the outside, which could allow pests to enter.”
The guidelines of the suspension allow Sunland to request an informal hearing to discuss issues related to the order. According to the FDA, the hearing is to be held as soon as possible but not later than 2 business days after the issuance of the suspension of registration order, unless an alternate time period is agreed upon. If after the hearing the FDA requires the suspension remain intact, Sunland must submit a corrective action plan to address the immediate problems and to implement sustainable solutions in a sound scientific manner. Sunland’s facility registration will be reinstated only when the FDA is satisfied the company can manufacture safe products.
For a list of recalled products and more information on the violation history of Sunland Inc., go to fda.gov.