Sunland Inc. said the Food and Drug Administration’s suspension of its facility registration was disappointing and unexpected. The F.D.A. suspended Sunland from marketing or distributing its products into commerce on Nov. 26.
In a statement issued by the company, Sunland Inc. said it had “Shut down operations in its peanut butter plant just prior to initiating its voluntary recall on Sept. 24, 2012, and shut down shelling operations in its separate peanut mill when the recall was expanded in October. During the last two months Sunland has been working with experts as well as with F.D.A., analyzing data, and developing and implementing proposed corrective actions in order to be in a position to reopen first the shelling plant and then the peanut butter plant. These plans were submitted to F.D.A. in our response to the inspection observations.”
The company said it has hoped to recommence shelling operations on Nov. 26 and informed the F.D.A. of its plan in a letter dated Nov. 20.
“Sunland expected that any agency concerns with its plans would be part of the ongoing dialogue with the agency,” the company said. “The agency’s order suspending Sunland’s registration on Nov. 26, 2012, was unexpected and the company is disappointed by this development.
“Sunland's goal remains the same — to take all appropriate measures for the safe processing and handling of raw peanuts in its shelling plant and the safe production of nut butter products in its peanut butter plant. Sunland is continuing to work with F.D.A. in order to accomplish all steps necessary to begin shelling operations in its peanut mill as soon as possible.”
In announcing the suspension of Sunland’s registration, the F.D.A. said a review of Sunland’s product testing records showed that 11 product lots of nut butter showed the presence of Salmonella between June 2009 and September 2012. Between March 2010 and September 2012, at least a portion of eight product lots of nut butter that Sunland Inc.’s own testing program identified as containing Salmonella was distributed by the company to consumers.
Additionally, during its inspection of the plant in September and October 2012, the F.D.A. said it found the presence of Salmonella in 28 environmental samples and in 13 nut butter product samples and one product sample of raw peanuts. Four of the peanut butter product samples showed the presence of the outbreak strain of Salmonella Bredeney.
The F.D.A. said it will only reinstate Sunland’s registration when it determines the company has developed and implemented procedures to product safe products.
