Sunland has denied releasing any products that it knew to be contaminated after a US FDA inspection showed that peanut or almond butter was distributed despite the firm’s testing system identifying the presence of salmonella.
Sunland Inc, the manufacturer of peanut butter products confirmed as the source of an outbreak of the foodborne illness, responded after the Food and Drug Administration (FDA) made an inspection report of the firm’s facility public.
The FDA identified products from June 2009 to August 2012 that tested positive for salmonella through the firms’ internal testing system but were cleared for partial distribution.
“Since 2009, your firm has distributed lots of peanut butter and nut butters that were positive for Salmonella… products since 2009 that have been manufactured by your firm, have tested positive for Salmonella by your firm's internal testing program, and were at least partially distributed by your firm,” said the report.
In the latest update the contaminated product had led to 41 illnesses in 20 states.
In a statement published on their website the company’s president and CEO, Jimmie Shearer, said it would not publicly discuss its responses until the FDA has completed its review.
“At no time in its twenty four year history has Sunland, Inc. released for distribution any products that it knew to be potentially contaminated with harmful microorganisms,” the statement 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.”
The FDA also identified products from May to September this year that tested positive for salmonella through their testing despite the internal testing program identifying them as not being positive
“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.”
The statement added that the firm has submitted a comprehensive point by point response to the Form 483 observations issued at the close of the inspection.
“We believe that drawing any inferences much less conclusions about the company's practices based solely on the observations as set forth in the Form 483 without considering the company's response would be wholly premature and unduly prejudicial to Sunland.
“The company believes that its response to the Form 483 will not only help the agency understand the company's decision-making process but also lead the agency to confirm that such decision-making was, at all times, conducted in good faith.”