The Abbott Nutrition said it reached a deal with the US Food and Drug Administration to resume production of its infant formula in the state of Michigan after it was shutdown by the federal government over contamination concerns.
“Abbott has agreed to enter into a consent decree with the US Food and Drug Administration (FDA) related to its Sturgis, Mich[igan], infant formula plant,” the company said in a press release on Monday.
“The decree is an agreement between FDA and Abbott on the steps necessary to resume production and maintain the facility… The decree is subject to court approval.”
The United States is facing a shortage of infant formula that has been developing for many months and became more acute in February.
On February 17, Abbott Nutrition, the largest infant formula manufacturer in the country, initiated a voluntary recall of several lines of powdered formula. This came after concerns about bacterial contamination at Abbott’s Michigan facility after four infants fell ill and two died.
The company said in the press release that the US Centers for Disease Control and Prevention (CDC) concluded its investigation into the contamination issues and found no link between Abbott’s infant formula and the babies that became ill.
The Michigan plant could resume production of infant formula within two weeks once the FDA gives a final approval to reopen but it could take up to eight weeks to get more product on shelves at US stores, the release said.