(ABBOTT PARK, IL) – An agreement has been reached to re-open the Abbott plant in Sturgis.
Abbott Nutrition has agreed to enter into a consent decree with the U.S. Food and Drug Administration to re-open the Sturgis infant formula plant. The decree is an agreement between Abbott and the FDA on the steps that are necessary to resume production and maintain the facility. It is subject to approval by the courts.
Abbott Chairman and Chief Executive Officer Robert B. Ford says the company's number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening the Sturgis facility to ease the nationwide formula shortage. Ford says Abbott looks forward to working with the FDA to quickly and safely re-open the facility.
In addition, Ford says millions of parents and caregivers depend on Abbott and they are deeply sorry that their voluntary recall worsened the nationwide formula shortage. He says Abbott will work hard to re-earn the trust that moms, dads and caregivers have placed in their formulas for over 50 years.
On February 20, Abbott voluntarily recalled three powder formulas that were manufactured in Sturgis: Similac, EleCare and Alimentum. The recall was done after four consumer complaints related to Cronobacter sakazakii and Salmonella Newport in infants.
Abbott says during the investigation in Sturgis, Cronobacter was found in non-product contact areas, and has not been linked to any known infant illness. Genetic sequencing on the two available samples from ill infants did not match strains of Cronobacter in the Sturgis plant. The samples from the ill infants did not match each other, meaning there was no connection between the two cases.
Once the FDA confirms the initial requirements for start-up have been met, Abbott could restart the site within two weeks. They would begin production of EleCare. Alimentum and metabolic formulas first and then begin production of Similac and other formulas.
From the time Abbott restarts the site, it will take six to eight weeks before product is available on shelves.
Ford says Abbott will continue to import formula from an FDA-registered facility in Ireland to help alleviate near-term supply shortage.
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