The Department of Justice (DOJ) is investigating Abbott Laboratories for its actions that led to the closing of its Sturgis, Michigan, factory last year. The facility’s shutdown contributed to a nationwide baby formula shortage.
The Wall Street Journal reported the DOJ launched a criminal investigation, which the company said it has been informed of and is fully cooperating. The probe is being carried out by the DOJ’s consumer-protection branch.
Abbott Laboratories is based outside of Chicago and manufactures Similac, among other baby formula brands.
The saga began with a whistleblower report of unsanitary conditions within the facility. The Food and Drug Administration (FDA) found a deadly bacteria in the plant similar to the one that infected several infants. The plant’s closing was accompanied by a recall of its baby formula products.
A settlement agreement was reached with the company to reopen, but the damage was done. U.S. consumers went several months without reliable access to baby formula, including specialized products for children with specific needs.
The crisis spotlighted shortcomings in the nation’s baby formula supply chain. The $4 billion industry bottlenecked and empty shelves across the country soon followed.
Families were sent scrambling to find enough to feed their children, and the White House resorted to flying in shipments internationally.
— Ellen Kagan (@kagan_ellen) January 22, 2023
The Journal quoted Seattle attorney Bill Marler, who said the DOJ has successfully prosecuted defendants in food contamination cases even when they did not act with criminal intent.
Health officials were never able to definitively link the Abbott plant to the bacterial strains that infected several infants. Company officials noted that the strains found in infected infants did not match those found at the facility.
Still, there were numerous issues found at the Sturgis facility, including defective formula cans, damaged drying equipment, and standing water.
Because of the infractions, the plant stayed closed from February until June of last year. It was finally reopened with assurances that procedures would be modified to prevent further issues.
The controversy surrounding the plant spilled over to President Joe Biden’s FDA when it was revealed that its top safety official was not informed until months after the whistleblower report was filed. Administration officials also faced intense criticism for their slow response to the crisis.