Abbott Labs under criminal investigation over baby formula shortage: Report
The Justice Department is investigating conduct at the Abbott Laboratories infant-formula plant in Sturgis, Michigan
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The Justice Department is investigating Abbott Laboratories' baby formula plant in Michigan, which was at the center of a nationwide formula shortage that plagued millions of families, the Wall Street Journal reports.
In May, Abbott reached an agreement with the Food and Drug Administration (FDA) to reopen the company’s manufacturing plant in Sturgis, Michigan to help ease a nationwide shortage of baby formula, after the facility was closed due to bacterial contamination.
Shelves with baby formula are pictured at Skippack Pharmacy with a shopper limit amid continuing nationwide shortages in Schwenksville, Pennsylvania, U.S., June 2, 2022. (Reuters Photos)
Shelves typically stocked with baby formula sit mostly empty at a store in San Antonio, Tuesday, May 10, 2022. Parents across the U.S. are scrambling to find baby formula because supply disruptions and a massive safety recall have swept many leading (AP Photo/Eric Gay / AP Newsroom)
FDA Commissioner Robert Califf said Abbott, under the conditions of the agreement, would correct insanitary conditions that led to the contamination and plant closure.
"The DOJ has informed us of its investigation, and we’re cooperating fully," an Abbott spokesman told the Wall Street Journal.
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The investigation signals further scrutiny of Abbott’s operation of the plant, a major source of baby formula in the U.S.
An Abbott Laboratories manufacturing plant is shown in Sturgis, Mich., on Sept. 23, 2010. (Brandon Watson/Sturgis Journal via AP / AP Newsroom)
Yury Navas, 29, of Laurel, Md., kisses her two-month-old baby Jose Ismael Gálvez, at Superbest International Market in Laurel, Md., Monday, May 23, 2022, while looking for formula. (AP Photo/Jacquelyn Martin / AP Newsroom)
Last January, FDA inspectors found the cronobacter pathogen at the plant after receiving reports of babies who drank the company’s formula and became sick. The bacteria that was detected in the supply found let to at least four infant illnesses-including two deaths.
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The inspectors also found standing water, damage to drying equipment and defects in the seams of formula cans, among other problems at the Sturgis plant.
A woman shops for baby formula at Target in Annapolis, Maryland, on May 16, 2022, as a nationwide shortage of baby formula continues due to supply chain crunches tied to the coronavirus pandemic that have already strained the countrys formula stock, (Photo by Jim Watson/AFP via Getty Images / Getty Images)
In a 10-page report published in September, the FDA stated that conditions observed at the Abbott facility "were not consistent with a strong food safety culture."
Abbott temporarily halted production at the Sturgis factory in February, and recalled baby formula made at the plant.
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The move sparked a national formula shortage which forced the U.S. to airlift millions of pounds of powdered formula from overseas.