F.D.A. suspends Sunland's facility registration
WASHINGTON — The Food and Drug Administration has suspended the food facility registration of Sunland Inc., and the company is now prohibited from selling or distributing food into the marketplace. This is the first time the F.D.A. has used its facility registration suspension authority, which was granted under the Food Safety Modernization Act.
The F.D.A. said a review of Sunland Inc.’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.
In a Nov. 15 statement, Sunland said, “The company has followed internal testing protocols that it believed resulted in the isolation and destruction of any product that did not pass the test designed to detect the presence of any contaminants. In every instance where test results indicated the presence of a contaminant, the implicated product was destroyed and not released for distribution. The company believed at all times that its response was sufficiently robust such that any product which might be contaminated was isolated and destroyed.”
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.
Sunland now has an opportunity to request an informal hearing related to its suspension. If the F.D.A. determines that the suspension is necessary, Sunland will be required to submit a corrective action plan to address the immediate problems and implement a “sustainable” solution to the problems, according to the agency.
The F.D.A. said it will only reinstate Sunland’s registration when it determines the company has developed and implemented procedures to produce safe products.