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Tuna company StarKist Co. had serious violations of federal food safety laws at its processing plant in American Samoa, according to the Food and Drug Administration.
During an inspection on November 1 through 4 of 2010, the FDA found various violations at the plant, including temporary storage of tuna in conditions that could result in the proliferation of the bacteria Staphylococcus aureus, which may lead to production of an enterotoxin that can cause food poisoning and is heat stable.
"Accordingly, your canned tuna and pouched packed tuna are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health," the FDA wrote in a letter to the company on March 1.
The agency also found that the company didn't properly ensure that its packaged tuna is hermetically sealed, which means that pathogenic bacteria in the environment might be able to enter. The FDA requested copies of company documents detailing the production of StarKist tuna in 3 oz. and 43 oz. pouches produced at the American Samoa processing plant between August 1, 2010 and November 4, 2010.
StarKist's Director of Quality Assurance John Aaron Maxfield said these documents were not part of the company's food safety program and the FDA says that they were refused access, according to the letter.
Without an adequate response from the company within 15 working days of receipt of the letter, the company could face sanctions from the agency, including "further action to seize your product(s) and/or enjoin your firm from operating. We may also refuse admission of your tuna product...including placing them on detention without physical examination."
However, StarKist spokeswoman Mary Sestric said the company's products are safe and that it isn't announcing any recalls or withdrawals.
The company's food safety plan "incorporates the FDA's current guidance to the seafood industry," Sestric said. "Our [plan] is further reinforced by annual internal food safety team reviews, as well as third-party audits."
When asked if the company tested for Staphylococcus aureus during the time period in question by the FDA, Sestric said "microbiological growth concerns such as this are thoroughly addressed by StarKist's current food safety program. Our existing process controls meet or exceed industry standards to control the proliferation of all microbiological hazards, in addition to the canning process, which deems the product commercially sterile."
The FDA issued the warning letter to help the company ensure it doesn't produce any contaminated product. The agency can ask for a voluntary recall, or issue one if necessary, but hasn't because it found no contaminated product, said agency spokesman Douglas Karas.
StarKist Co., a wholly owned subsidiary of the Dongwon Group, and is based in Pittsburgh, Penn.
Read more warning letters from the FDA to other companies.
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