After food safety shutdown, Abbott, FDA reach deal to reopen Sturgis formula plant amid shortage
The nationwide baby formula shortage has a local connection — some of the issues can be traced back to the February shutdown of an Abbott plant in Sturgis, Mich. following an outbreak of bacterial infections potentially linked to formula produced there.
But the plant could soon be back open following an agreement between Abbott and U.S. officials that allows the plant to restart production after the Food and Drug Administration verifies bacterial contamination issues have been fixed.
It’s a key step towards easing the nationwide formula shortage, but it will still be at least two months before any new product ships.
The Sturgis plant — Abbott’s largest domestic facility — has been idle after several babies became ill from drinking formula produced there. Two later died from bacterial infections, and all formulas manufactured at the plant were recalled.
The first case was reported in September 2021 on the same day the Food and Drug Administration inspected the Sturgis plant and found no serious violations.
But following the outbreak, the FDA returned four months later in early 2022 and found five strains of Cronobacter sakazakii in the facility. That led to the shutdown and recall on February 17.
According to a whistleblower complaint from a former plant employee that was filed with the FDA in October 2021, the Sturgis facility had long-standing food safety issues — some of the equipment used in the manufacturing process was in need of repairs.
Other alleged problems included the falsification of records, lax cleaning practices and the release of infant formula that wasn’t tested for bacterial contamination.
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