Abbott Nutrition on Saturday resumed baby formula production at its Sturgis, Michigan, plant, a move toward addressing a nationwide shortage.
The company has been given the green light from the U.S. Food and Drug Administration after meeting “initial requirements” as part of a May 16 consent decree.
The company said it will restart the production of EleCare, a formula for children who struggle to digest other products, along with other specialty and metabolic formulas.
Abbott aims for an initial EleCare product release around June 20 and is working to meet guidelines to resume production of Similac and other formulas.
“We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America,” a spokesperson for Abbott said in a statement. “We will ramp production as quickly as we can while meeting all requirements.”
While supply problems started early in the Covid-19 pandemic, issues worsened in part due to the February closure of the Michigan plant amid scrutiny over contamination.
FDA investigations began after four infants were hospitalized with bacterial infections from drinking its powdered formula. Two of the babies died.
“The FDA is continuing to work diligently to ensure the safe resumption of production of infant formula at Abbott Nutrition’s Sturgis, Michigan, facility,” the FDA said in a statement.
“The agency expects that the measures and steps it is taking, and the potential for Abbott Nutrition’s Sturgis, Michigan, facility, to safely resume production in the near-term, will mean more and more infant formula is either on the way to or already on store shelves moving forward,” the FDA said.
Abbott Nutrition is the largest baby formula manufacturer in the U.S.