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Abbott Nutrition said it reached an agreement with the Food and Drug Administration to restart production at its largest U.S. factory as the U.S. faces a serious baby formula shortage related to its plant's closure.
The FDA and Abbott reached a consent degree on Monday to re-open Abbott’s Sturgis, Michigan plant.
"We look forward to working with the FDA to quickly and safely re-open the facility," Abbott CEO Robert Ford stated in a press release. "We know millions of parents and caregivers depend on us and we're deeply sorry that our voluntary recall worsened the nationwide formula shortage."
With FDA approval, Abbott could re-open its Michigan plant within two weeks and ship formula to grocery store shelves within six to eight weeks from that point.
The plant shut down earlier after four infants became sick, two of whom died, after consuming formula from the Michigan plant.
"After a thorough investigation by FDA, Centers for Disease Control and Prevention (CDC) and Abbott, and review of all available data, there is no conclusive evidence to link Abbott's formulas to these infant illnesses," the company emphasized.
The Biden FDA was aware of potential issues at the Michigan factory in September 2021, but failed to take action.
On NBC’s Today Show on Monday, Food and Drug Administration Commissioner Robert Califf announced a full investigation into why his agency was slow to react to the baby formula crisis.
“We always want to be as fast as we can possibly be while also being diligent, remembering, as shown by this example, that if we didn’t close the plant, then we have a supply shortage so we have to get this right,” Califf said on TODAY.
“There will be a full investigation of the timeline, and we’ll do everything possible to correct any errors in timing that we had so that we don’t repeat any mistakes that may have been made,” he emphasized.
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