WASHINGTON — Baby formula maker Abbott said it has reached a deal with U.S. health regulators to restart production at its largest domestic factory in Sturgis, Michigan.
We’ve agreed to enter into a consent decree – a legal agreement – with the FDA for our Sturgis, Mich., plant, a major step toward reopening our facility and helping to ease the infant formula shortage.
— Abbott (@AbbottNews) May 16, 2022
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In a news release sent Monday afternoon, Abbott agreed to restart the factory within two weeks.
“Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely re-open the facility,” said Robert B. Ford, chairman and chief executive officer, Abbott. “We know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years.”
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Abbott did not immediately detail the terms of the agreement reached with the Food and Drug Administration, which has been investigating safety problems at the Sturgis, Michigan, facility. The consent decree is a binding legal agreement between the company and the federal government.
After production resumes, Abbott said it will take at least eight weeks to begin shipping new product to stores, according to the Associated Press.
Ongoing supply disruptions combined with a safety recall led to the shortage.
Disruptions in labor, transportation and raw materials caused by the COVID-19 pandemic led to supply chain issues. The problem was exacerbated by consumers stockpiling supplies, such as formula, during COVID-19 lockdowns.
In February, Abbott recalled several brands of powdered formula and shut down its factory in Sturgis, Michigan. Four children became ill after they were given formula contaminated with Cronobacter bacteria. Two babies died.
Abbott is one of only a handful of companies that produce the vast majority of the U.S. formula supply. The recall wiped out a large segment of the market.
Check back for more on this developing story.
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