WASHINGTON — Abbott said it has stopped production of EleCare formula in its Sturgis, Michigan facility after "torrential storms" flooded the area, including parts of the plant.
Abbott said Wednesday that production and distribution of new formula will likely be delayed by "a few weeks". The company had stopped production of the formula to assess damage caused by the storm and clean the plant.
"We have informed FDA and will conduct comprehensive testing in conjunction with the independent third party to ensure the plant is safe to resume production," Abbott said in a release.
FDA chief Robert Califf said the closure was an "unfortunate setback," but one that would be offset by the government's efforts to address the shortage.
"We know Abbott is working quickly to assess the damage and will be reporting its progress to us in the days ahead," Califf wrote on Twitter. "Once the company establishes a plan, FDA will be back in the facility working to ensure that they can restart producing safe and quality formula products quickly."
Abbott said once the facility is re-sanitized and production resumes, it will restart EleCare production, then specialty and metabolic formulas. It also will "work to restart Similac production ... as soon as possible."
Abbott closed the factory in February after the FDA began investigating four bacterial infections among infants who consumed powdered formula from the plant. Two of the babies died. The company continues to state that its products have not been directly linked to the infections, which involved different bacterial strains.
FDA inspectors eventually uncovered a host of violations at the plant, including bacterial contamination, a leaky roof and lax safety protocols. The FDA has faced intense scrutiny for taking months to close the factory and then negotiate its reopening.
Abbott’s February recall of several leading brands, including Similac, squeezed supplies that had already been strained by supply chain disruptions and stockpiling during COVID-19 shutdowns.
Abbott said Wednesday it has "ample existing supply of EleCare and most of its specialty and metabolic formulas to meet needs for these products until new product is available."
The company said its facilities minus Sturgis produced 8.7 million pounds of infant formula in June -- "95% of what we produced in January, prior to the recall".
The Associated Press contributed to this report.