January 27, 2023

DOJ Starts Criminal Investigation into Abbott Over Formula

According to news reports, the Department of Justice has started a criminal investigation into Abbott Laboratories in relation to the cronobacter contamination at the Abbott plant that caused a shutdown last year and the resulting baby food supply crisis that triggered a severe shortage of powdered baby formula. Cronobacter can cause serious illness in infants and can be deadly.

DOJ Starts Criminal Investigation into Abbott Over Formula

In September 2021, an infant in Minnesota developed a cronobacter infection. Minnesota is the only state in the country that requires reporting this illness. Minnesota officials reported the issue to the Centers for Disease Control and Prevention (CDC). Babies in Ohio and Texas also got sick; the infant in Ohio died. In all, four infants were sickened and two babies died.

With more infants sick, FDA then┬álaunched an investigation into conditions at the Sturgis plant. And Abbott closed the plant. In February 2022, multiple baby formula products produced at Abbott Nutrition’s Sturgis, Michigan plant were recalled.

Investigators found multiple areas of Cronobacter sakazakii contamination in the plant, along with poor sanitary conditions. Form 483 filed by the FDA informed Abbott: “You did not maintain a building used in the manufacture, processing, packing, or holding of infant formula in a clean and sanitary condition.”

In the end, the cronobacter found in the Abbott plant did not match the patient isolates in any of the cases. However, a whistleblower warned the FDA that after the company was informed about the first infant death, they did not test Similac samples in their internal probe.

The DOJ is not commenting on their investigation, and neither is Abbott. We don’t know what the investigation is about, or if anything will come of it.

Meanwhile, in May 2022 Abbott entered a consent decree with the FDA, agreeing to abide by conditions before their plant opened again. The facility opened on July 1, 2022.

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