Less than two weeks after restarting formula production at its Michigan facility, Abbott has again had to halt manufacturing there amid flooding.
Storms in southwestern Michigan Monday night overwhelmed the stormwater system in Sturgis, Mich., causing flooding in the city and parts of the plant, Abbott said in a statement.
As a result, Abbott has stopped production of its EleCare formula, a formula for babies and children with allergies and certain gastrointestinal disorders. Abbott is assessing damage caused by the storm and cleaning and re-sanitizing the facility. It will likely be “a few weeks” until production and distribution of new products can resume, Abbott said.
Abbott said 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 news, however, comes as parents across the country continue to struggle with a shortage of infant formulas. Many had looked forward to the reopening of the Sturgis plant a couple weeks ago as a sign that supplies might soon be replenished.
Supply chain issues initially caused a shortage of infant formulas, and then a recall of formulas produced at Abbott’s Sturgis plant exacerbated the issue.
The issue has sparked outcry from parents, whose babies rely on certain types of formula, and from lawmakers who have criticized Abbott for conditions at its facility and the U.S. Food and Drug Administration for not catching the problems earlier. Abbott is also facing a number of lawsuits from parents.
Abbott recalled the formulas in February as the U.S. Food and Drug Administration announced that it was investigating complaints of Cronobacter sakazakii infections among four babies who reportedly consumed formula made there. All four were hospitalized, and Cronobacter may have contributed to two babies’ deaths, according to the FDA.
The FDA inspected the facility from Jan. 31 through March 18 and found five environmental subsamples collected from the Sturgis facility to be positive for Cronobacter sakazakii, though product samples collected by the FDA at the facility were negative for Cronobacter.
Abbott leaders have apologized for the company’s role in the national shortage. Abbott, however, has said that the Cronobacter that was found in environmental testing during the investigation was in “non-product contact areas of the facility and has not been linked to any known infant illness.”
FDA Commissioner Dr. Robert Califf has also acknowledged that the FDA was “too slow” to inspect the plant and interview a whistleblower about conditions there. The FDA got a complaint in September about an infant who became ill after consuming formula made at the Michigan facility, and received a whistleblower complaint in October.
Abbott said once it can restart production in Sturgis, it will produce more EleCare, followed by specialty and metabolic formulas, and Similac.
Parents who need EleCare or specialty formulas should contact their doctors or Abbott at 1-800-881-0876.
