The company said if the agency approved reopening the plant, production could resume and store shelves would be restocked within several weeks.
The Food and Drug Administration on Monday reached an agreement with Abbott Laboratories on the steps needed to reopen the company’s shuttered baby formula plant, which could begin to ease the shortage of infant formula that has frightened and exasperated parents nationwide. The F.D.A. must still grant approval, once the company has taken the steps, for production to resume at the plant in Sturgis, Mich. It has been shut down since February after several babies who had consumed formula that had been produced there fell ill and two died. Abbott described the agreement with the F.D.A. as a “consent decree” and said it would require federal court approval. Once the agency permits the plant to reopen, the company said production could begin within about two weeks and could translate to more formula on shelves in six to eight weeks. The company said it will continue flying formula in from a plant in Ireland. It was unclear how soon the F.D.A. might approve the plant reopening. Abbott’s plant has been offline since February, when the F.D.A. discovered a deadly bacteria, called cronobacter, while swabbing in and near production lines. Abbott disputed that characterization, saying the bacteria were found in “high care” areas that indicate proximity to open products, but not necessarily in or on the production lines themselves. The same type of bacteria has been linked to four recent infant illnesses and two deaths in Minnesota, Texas and Ohio. Abbott said “there is no conclusive evidence to link Abbott’s formulas to these infant illnesses.”
The plant shutdown exacerbated an existing supply crisis, as parents rushed to stock up on formula.
