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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

FDA Sends Warning Letter to “Quality Egg”

hens_in_cages.jpgQuality Egg still does not seem to get it. According to Bloomberg News, Quality Egg LLC, the producer tied to a salmonella recall, may face U.S. enforcement action unless it fixes health violations at its facilities, regulators said. Conditions that may cause salmonella weren’t addressed when regulators inspected Galt, Iowa-based Quality Egg’s facilities Aug. 12 to Aug. 30, the Food and Drug Administration said in a warning letter posted today on its website. A lack of action may result in “seizures and/or injunction,” the agency said. Quality Egg submitted information to the FDA on Oct. 5 reflecting “discussions with the agency” of corrective actions, the agency said Oct. 15 in the letter. The FDA will inspect facilities to verify those steps were taken, the agency said. The salmonella outbreak is the largest since the Atlanta- based CDC began tracking the illness more than 30 years ago.

  • Thanks for the link to the warning letter.
    The warning letter clearly shows me the following:
    1. The existing combination of the Public Health Service Act (PHSA) and the Federal Food, Drug and Cosmetic Act (FFDCA) give the FDA all the authority needed to have prevented this outbreak or, at the very least, to have substantially, reduced the size of the outbreak.
    2. The FDA is taking an auditing stance on violations rather than an inspection stance.
    3. The FDA is conflating its roles of investigation and enforcement into a single quasi-judicial role.
    4. The FDA continues to describe the cases of illness resulting from Quality Eggs’ and Hillandale’s shell eggs and pasteurized egg products made from those eggs as if they are a single outbreak.
    5. The overall weakness of the FDA performance.
    Finally, it is VERY IMPORTANT TO NOTE that this warning letter does not in any way address the fact that contaminated eggs from Wright County Egg were shown by lab tests to be the source of the April 2010 outbreak at Bullock’s Bar-B-Que in Durham, NC and, quite probably, other restaurants. In that case, PASTEURIZATION of the egg whites did NOT stop the SE from making people sick. And there has been NO REQUEST BY THE FDA TO RECALL of any of those products despite their long shelf life.
    The FDA’s approved method of dealing with SE contaminated egg (i.e., pasteurization) did not eliminate the hazard of those eggs. They still made people sick.