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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

FDA’s Inspection Report For Nestle’s Danville, Virginia Facility – FDA’s 483 – Released to Nestle on Thursday – The Rest of Us, When?

From a Nestle’s Press Release:

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.

It will be interesting to see what the 483 says when the FDA releases it to the rest of us.  So much for transparency.