On June 29, 2009, the FDA confirmed evidence of E. coli O157:H7 in a retained production sample of 16.5 oz. Nestle Toll House refrigerated chocolate chip cookie dough bar. The product has a day code of 9041 and a "Best before 10 JUN 2009" notation. "We are very concerned about those who have become ill from E. coli O157:H7 and deeply regret that this has occurred," said Paul Bakus, General Manager of Nestle's Baking Division.
Today, the FDA provided its summary findings resulting from its recent inspection of the Nestle Danville facility. The report is called a "Form FDA 483". The 483 reflects the inspector's observations and is designed to ensure that the company's manufacturing operations are in compliance with current regulatory requirements.
Federal investigators, who spent more than a week at the Danville facility, did not detect E. coli O157:H7 inside the factory or on equipment. Nestle testing reflects the same results.
The 483 reported two observations. Neither of these observations is believed to have any relationship to the presence of E. coli O157:H7 found in the retained production sample. The first observation was related to the design of a gate valve used on a hopper for dry ingredients. The valve required a smoother and more polished surface to allow for easier cleaning. The second observation noted by the FDA was condensate dripping from a refrigeration pipe onto a metal "rake" (i.e., a large metal spatula) used to scrape cookie dough from the mixer. Both of the observations have been corrected.
As part of the inspection, and through additional independent testing, more than 1,000 tests have been performed at the Danville facility, including extensive environmental sampling and analyses. Nestle also dismantled its production lines for thorough inspection, conducted extensive testing on equipment and ingredients, and has carefully reviewed its quality and food safety procedures. To validate these procedures, a controlled production is being phased-in on a few production lines. Scientists from the FDA, CDC, and The United States Department of Agriculture (USDA) have been working along with nine Nestle PhD microbiologists on this comprehensive investigation.
Nestle announced the voluntary recall of all Nestle Toll House refrigerated cookie dough on June 19, 2009. Because the health and safety of our consumers is so important, we began the recall while the investigation was underway. The recall does not include other Nestle Toll House products, including already baked Toll House cookies purchased outside the home, all varieties of Nestle Toll House morsels, chocolate baking bars, or cocoa, and Dreyer's and Edy's ice cream products with Nestle Toll House cookie dough ingredients.
The recall also does not include any Nestle Professional(TM) cookie dough products that were destined for food service use, including frozen Nestle Toll House cookie dough and cookie dough "mix-ins" purchased outside the home.
