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Abbott enters Consent Decree with FDA on Cronobacter infant formula outbreak and recall

Bill Marler

Here are the highlights of the Consent Decree : Abbott has agreed to take corrective actions following an FDA inspection of its Sturgis, Michigan facility. It also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected.

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Elevated Lead Levels in Cinnamon prompt FDA Warning and Recalls

Bill Marler

Through product testing, the FDA has determined that the ground cinnamon products listed in the table below contain elevated levels of lead and that prolonged exposure to these products may be unsafe. The FDA is advising consumers to throw away and not to buy these ground cinnamon products. What is the problem?

FDA 276
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Lead Chromate contamination in Cinnamon was intentional says FDA

Bill Marler

The FDA has confirmed that lead chromate is the source of lead and chromium in cinnamon applesauce marketed for children and imported from Ecuador. Leaders at the FDA continue to believe the contamination was intentional. FDA’s leading hypothesis remains that this was likely an act of economically motivated adulteration.”

FDA 257
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FDA has its hands full with 10 open investigations

Bill Marler

A new outbreak of infections from Listeria monocytogenes has been reported by the FDA, bringing the agency’s number of open investigations to 10. The FDA has not identified a source of the pathogen but has initiated traceback efforts. Other outbreaks with active FDA investigations. It has not initiated traceback efforts.

FDA 265
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FDA: Another infant death likely linked to Abbott formula

Bill Marler

The FDA apparently became aware of the death on June 10, 2020. So far, the FDA has received 129 complaints linked to Abbott formula products, including 119 since the product recall in February. According to the FDA, this would bring the total to five illnesses with three deaths. Attorney sued Abbott and several employees.

FDA 269
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No one asked my opinion of FDA organization, but that seldom stops me

Bill Marler

Some might have heard that the FDA Commissioner has instituted a review on how the FDA, and it’s Food Safety arms or organized. Setting aside that it might be a good idea to create a single food safety agency with all the parts of USDA and FDA, etc., Any brilliant ideas? Any brilliant ideas?

FDA 281
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FDA review panel picked to help fix FDA

Bill Marler

Dr. Jane Henney, former FDA Commissioner, was named as Chair of the panel last month. This team brings the right combination of FDA and other government experience along with deep subject matter expertise and first-hand systems and operations knowledge,” said Jane E.

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