Abbott Laboratories is under investigation by the U.S. Department of Justice (DOJ) almost a year after the Sturgis baby-formula plant closed when illnesses were reported. First reported by The Wall Street Journal, the DOJ’s consumer protection branch is looking into conduct at the plant that led to its shutdown.
“The Department of Justice has informed us of its investigation and we’re cooperating fully,” Abbott spokesperson Scott Stoffel said via email to Watershed Voice. He declined to provide further details.
Abbott is just one of four companies that produces 90 percent of U.S. formula, and its closure in February 2022 sparked a nationwide baby formula shortage, which forced parents to seek formula from food banks, friends, and doctor’s offices. According to a report from The Associated Press, the shortage was especially problematic for children with allergies, digestive problems, and metabolic disorders who rely on specialty formulas, and the Abbott factory is the only source of many of those products.
The U.S. Food and Drug Administration zeroed in on Abbott’s plant after tracking several bacterial infections in infants who had consumed formula from the facility. The four cases of sick babies resulted in hospitalizations and two deaths. Abbott closed its doors when the FDA investigation began, and inspectors uncovered several violations including bacterial contamination, a leaky roof, and lax safety protocols. A massive recall of Abbott’s formulas was announced on February 17, 2022 when the FDA discovered positive samples of a rare-but-dangerous bacteria in multiple parts of the facility. The February recall included Similac, Alimentum, and EleCare labels.
The company signed a consent decree with the federal government in May 2022, which laid out what it would do before re-opening the plant. The consent decree, which requires court approval, laid out the required steps to safely restart production and maintain the site in Sturgis. Under the agreement, the Sturgis facility will be required to retain an independent expert to review operations and ensure that it follows the law. The decree also included measures for testing products and halting production in the event of contamination. Production restarted in June 2022.
“Abbott is committed to working with regulators, independent experts and others to set a new standard in infant formula safety and quality,” Abbott said an official statement. “We know getting your baby high-quality infant formula is your priority and it’s ours too.”
Beca Welty is a staff writer and columnist for Watershed Voice.