The US Department of Justice said it reached a tentative agreement with Abbott Laboratories to resolve safety issues at its Sturgis baby formula plant
Washington — The US Department of Justice confirmed Monday that it reached a tentative agreement with baby formula manufacturer Abbott Laboratories to resolve safety issues at its plant in Sturgis, Michigan, where a recall has helped to fuel a nationwide formula shortage. In a Monday evening statement, the federal agency said it had filed a legal complaint against Abbott over allegations of quality and safety violations and that the company had already agreed to a proposed consent decree to resolve the issues. The decree is subject to court approval. The agreement, which was announced earlier in the day by Abbott, could eventually clear a path for the manufacturer to restart formula production at the Michigan facility in as soon as two weeks. The Sturgis plant is the country’s largest manufacturing plant for infant formula. Abbott’s recalled products included powder formula sold under the labels Similac, Alimentum and EleCare labels after four children became ill with bacterial infections and two died. Several Abbott employees are accused of manufacturing the baby formula under conditions that did not meet regulatory standards for quality and safety, according to a federal court filing. The consent agreement would require Abbott Laboratories to take a series of steps aimed at increasing safety at the facility and bring the company into compliance with federal regulations before it could resume operations.
“The actions we are announcing today will help to safely increase the supply of baby formula for families,” Attorney General Merrick Garland said in the statement. Abbott has stressed that tests by the FDA and the company showed that infant formula produced at the Sturgis facility is not likely the source of infection in the reported cases of illness. The company said earlier Monday the Centers for Disease Control and Prevention had concluded its investigation with « no findings of a link between Abbott formulas and infant illnesses. »
Abbott said it could restart production the site within two weeks pending approval of the Food and Drug Administration, and after that, it could take six to eight weeks before its product reaches store shelves. In the meantime, Abbott will continue importing formula from its FDA-registered facility in Ireland to help ease the shortage in the supply of powder infant formula, the company said. Abbott CEO and Chairman Robert B. Ford hailed the agreement as a « major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage. »
« We look forward to working with the FDA to quickly and safely re-open the facility », Ford said in a statement.
« 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. »
Under the proposed consent decree, Abbott would have to retain an outside expert to review its operations at the Sturgis facility and bring the plant into compliance.
