Baby formula manufacturer Abbott reaches deal with FDA deal to reopen Michigan facility

Large baby formula manufacturer Abbott has struck an agreement with federal authorities to reopen its closed Sturgis, Michigan, factory, which will help ease the severe countrywide shortage. The company stated on Monday that it has achieved a deal with the FDA to restart manufacturing at the plant within the next few weeks. Abbott CEO Robert Ford said, “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. We look forward to working with the FDA to quickly and safely re-open the facility.”

The specifics of the arrangement were not disclosed, but Abbott claimed that manufacturing might restart within the next two weeks. However, items will not be available for another six to eight weeks. FDA Commissioner Robert Califf explained that “Abbott is responsible for the timeline, but I’m very comfortable with what they said about two weeks.”

Parents have been racing to locate supplies in stores hours away from their homes or on social media platforms for an exorbitant price due to the current formula scarcity. The return of production at the Sturgis plant will reportedly help to alleviate the stress caused by the shortage, which began last summer and has gradually increased since then. In February, when the FDA received reports of several children being very sick with bacterial infections and two of them dying, Abbott paused production and recalled numerous formula products in the United States. The recall of several Abbott powdered formulas in February and the following factory closure put a burden on the market, which is controlled by only four companies, Abbott Nutrition, Reckitt Benckiser, Nestle, and Perrigo.

The CDC performed a comprehensive inspection of the company and concluded that the bacterium that caused the illnesses, Cronobacter sakazakii, was only discovered in non-product contact sections of the facility and had not been related to any known newborn disease. Cronobacter sakazakii infections in two of the newborns did not match the germs detected at the Sturgis plant, according to genetic sequencing.

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