The U.S. Food and Drug Administration (FDA) announced recently that it is disclosing more information about inspections and court actions, and now has a web portal on its enforcement activities as part of Phase II of the agency’s Transparency Initiative. Now, FDA’s enforcement and compliance-related activities will be more accessible, downloadable, and searchable online.
U.S. Marshals Seize Cheese from Brunkow Cheese Facility
On May 13, 2011, the U.S. Attorney’s Office, filed a complaint requesting that U.S. Marshals seize cheese products distributed by Brunkow Cheese of Wisconsin, Inc. Brunkow, a company based in Darlington, Wisconsin, manufactures, packs, labels, and distributes a variety of cheese products.
The complaint alleged that in February 2011, the U.S. Food and Drug…
A Bad Egg Revealed: FDA Releases Inspection Report of Wright County Egg
Today the FDA released its Form 483 Inspection Observation Report from the on-site inspections it recently conducted at Wright County Egg’s egg laying farms/plants, and the findings are nothing short of disgusting. Here are just a sampling of the conditions witnessed by FDA’s inspectors:
- Chicken manure located in the manure pits below the egg laying
The “Guess Who Inspects It Game”: Nestle E. coli Cookie Dough Edition
The recent (and still unfolding) E. coli O157:H7 outbreak linked to contaminated Toll House cookie dough manufactured by Nestle has no shortage of lessons to teach, including the reminder that this deadly pathogen can find its way into nearly any food product if sufficient care is not taken during its manufacture. But this sad outbreak is also a case study in the ridiculously complicated, and too-often ineffective, state of food safety inspection in the United States. What makes the outbreak such an excellent case-study is the fact that the Nestle plant located in Danville, Virginia was not only manufacturing Toll House cookie dough products, but also a variety of Buitoni flat and stuffed pastas, and pasta sauces. This made the plant what is called a “dual jurisdiction establishment” that fell under the regulatory authority of both the FDA and the USDA. And to make things even more interesting, Virginia Department of Agriculture and Consumer Services (VDACS) was performing routine plant inspections under contract with the FDA. So how come with all these agencies involved no one prevented the outbreak?
By way of background, the FDA has jurisdiction over all domestic and imported food products, except meat, poultry, or processed egg products, which fall under the jurisdiction of the USDA. But not all food products fall neatly on one side of the jurisdiction line or the other. For example, the products that Nestle manufactured for its Buitoni-brand fell on both sides of the line, with a few falling almost on the line. Meat-flavored pasta sauce would be inspected by the FDA, while meat sauce containing 3% or more of meat would be inspected by the USDA. The ravioli stuffed with cheese would be the responsibility of the FDA, while those stuffed with pork or prosciutto would be the responsibility of the USDA. Thus, if you look at the FDA Inspection Report from September 11 and 12, 2006, you will see that the inspector takes note of fettuccini and linguine being manufactured (FDA products), and chicken tortellini being manufactured (USDA product). Only the Toll House cookie dough products feel solely within the jurisdiction of the FDA. Nonetheless, the FDA plainly took note of all products being manufactured, without, however, making mention of whether or how what was found would be communicated to the USDA. Of course, since the USDA had an inspector onsite, and the FDA showed up in the plant only every year or so, it is the USDA that presumably knew much more about the plant.
Given the presence of the USDA in the plant on a daily basis, the obvious question then is what did the USDA know, and when did it know it? Another obvious question is: Could the USDA have prevented this outbreak from occurring? And, indeed, was it potentially in a better position to prevent this outbreak. (NOTE: As part of my firm’s investigation into this outbreak we are currently attempting to obtain the USDA inspection records for this plant.)
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Continue Reading The “Guess Who Inspects It Game”: Nestle E. coli Cookie Dough Edition
Nestle Plant Refused Full Cooperation with FDA
Two reports of past inspections were made public today. The most notable inspection occurred in September 2006 at the Nestle plant in Danville, Virginia where it manufactures cookie dough products, as well as stuffed pastas and pasta sauces. A number of deficiencies were noted as part of the inspection. These were:
Three live ant-like insects…
FDA inspections down amid food recalls
The FDA is conducting just half the food safety inspections it did three years ago, the Seattle Post-Intelligencer reports.
"We have a food safety crisis on the horizon," said Michael Doyle, director of the Center for Food Safety at the University of Georgia.
The cuts by the Food and Drug Administration come despite a barrage…