Washington Post headline: Baby formula factory says it’s still months away from production
Subheadline: The maker of Similac said it can resume work within two weeks of FDA clearance, but restocking store shelves will take months.
By Laura Reiley and Sam Easter
Today at 1:22 p.m. EDT
In February, the FDA ordered Abbott to shut down its production facility in Sturgis, which produces Similac, EleCare and several other leading powdered formulas. Cronobacter bacteria had been found in infants who consumed formulas produced at the Sturgis plant. Two infants became sick, and two died. This prompted a voluntary recall by Abbott as well as an FDA inspection that found the plant did not maintain acceptable sanitary conditions.
Abbott says that after a painstaking investigation, the FDA still has not been able to produce clear evidence linking its formulas to the infants’ illnesses and deaths. Abbott officials said they began implementing improvements and taking corrective actions before receiving the FDA’s letter detailing needed fixes on April 8. They have installed nonporous, easily cleanable and sanitary floors, added a 3D-augmented reality system to provide clearer images of product as it moves through the facility, and increased finished product sampling and testing.
In a statement this week, the company said it can resume production within two weeks if the FDA signs off. Once the facility reopens, Abbott says it will take six to eight weeks before the product is available on shelves.