Baby formula manufacturer Abbott Nutrition on Monday said it has reached an agreement with the Food and Drug Administration (FDA) on a path to restart operations at its Sturgis, Mich., plant.
The facility has been shuttered for more than three months while the FDA investigated whether powdered formula from the plant caused four babies to contract a rare bacterial illness. Two of them died, and a subsequent FDA inspection found unsanitary conditions at the plant.
Abbott said the FDA has not been able to definitively link its formula to the illnesses. The company said it has been making corrective improvements to address the FDA’s concerns.