"Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage," Abbott CEO Robert B. 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."
Abbott could restart production at the facility within two weeks, but it may be six to eight weeks before formula hits shelves.
The plant was temporarily shut down in February and several brands of powdered formula were recalled after the FDA started investigating four bacterial infections among infants who consumed formula made at the facility. Two of the infants died.
Abbott has denied that its products caused the illnesses, saying that genetic sequencing on samples from ill infants did not match the strains of bacteria found in their plant.
About 43% of the baby formula supply was out-of-stock last week, according to Datasembly, which tracks the supply across 155,000 stores in the United States.
The out-of-stock rate fluctuated between 2% and 8% for the first half of 2021, jumped to 23% in January of this year, then hit 33% in April.
The Justice Department filed a consent decree on Monday that will allow the Abbott plant to reopen once certain conditions are met, saying that Abbott "failed to comply with regulations designed to ensure the quality and safety of infant formula, including protection against the risk of contamination from bacteria."
FDA Commissioner Robert M. Califf also said the agency is looking to new steps regarding importing formula from overseas.
"We recognize the hardships that parents and caregivers have faced in obtaining infant formula and the FDA is focused on boosting the availability of the country’s supply of these products, including new steps regarding importation," Califf said Monday.
Abbott's brands account for about half of the baby formula market in the U.S.
The Associated Press contributed to this report.