In February of this year, the FDA issued a warning to consumers that it was investigating complaints of cronobacter and salmonella infections in four infants who had consumed powdered baby formula from Abbott Nutrition’s Sturgis, Michigan processing plant. Abbott then recalled the products in question, and has yet to restart production at the plant, causing the ongoing baby formula shortage in the US.
As more information unfolds about the events leading up to the recall and the conditions at the Sturgis plant, we are reminded of the important role that whistleblowers play in protecting public health and safety. In 2019, FDA inspectors learned that there was cronobacter in finished products produced at the Sturgis plant and that the company had inadequate testing practices, but did not take any regulatory action against the plant. Neither the FDA nor the Michigan Department of Agriculture and Rural Development inspected the plant again until September of 2021, when the FDA inspected the plant and found unsanitary conditions such as workers handling raw materials without adequately washing their hands. The FDA did not test for cronobacter or other pathogens in the plant.
The next month, a former quality assurance worker at the Sturgis plant sent a 34-page report to various FDA officials alleging that Abbott falsified testing records, tested empty cans rather than finished products for bacteria, sold untested products in a batch where cronobacter was found in other products,...
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