Abbott Nutrition and the Food and Drug Administration announced a deal on Monday to reopen an Abbott processing plant to produce more baby formula amid a nationwide shortage.
Abbott said the plant can be operation within two weeks of receiving FDA approval, but it will take six to eight weeks for baby formula produced at the plant to arrive on store shelves.
Abbott closed the facility in Sturgis, Mich., in February and initiated a product recall following reports of bacterial infections in four infants who were fed formula made at the plant, two of whom died, and an FDA investigation into the facility. The closure exacerbated an ongoing shortage of baby formula throughout the U.S.
Abbott said in a press release that “there is no conclusive evidence to link Abbott’s formulas to these infant illnesses.” The company said it will enter a “consent decree” with the FDA on procedures to reopen the facility.
“We know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years,” Abbott CEO Robert B. Ford said in a statement.
“Today’s action means that Abbott Nutrition has agreed to address certain issues that the agency identified at their infant formula production facility in Michigan,” FDA commissioner Robert Califf said in a statement. “The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards.”
Meanwhile, Abbott said it will continue to import baby formula from its processing plant in Ireland to help ease the shortage.