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Michigan baby formula factory, Abbott, reaches deal with FDA to reopen

baby drinking out of bottle
A national shortage in infant formula was exacerbated in February when federal regulators found contamination in Abbott Nutrition’s Sturgis factory. The company issued a recall and stopped production after at least five babies fell ill after ingesting the formula, with two dying. (Shutterstock)

The Michigan infant formula factory that was shut down amid a federal investigation into whether contaminated formula made several babies very ill said Monday it could resume production by the end of May.

Abbott Nutrition announced in a news release it has reached an agreement with the U.S. Food & Drug Administration to reopen its factory in Sturgis, a move that should help reduce nationwide powdered baby formula shortages by mid-summer.

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The agreement will be legally binding in the form of a consent decree that is subject to court approval, the company said.

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An official in the Biden administration also told reporters on Monday that the deal is imminent, according to multiple reports.

The Sturgis facility — operated by a division of Illinois-based Abbott — closed in February after it voluntarily recalled its Similac powdered formula along with other brands produced in the southwest Michigan factory.

The FDA first inspected the plant last September, when it found contamination risks. By the end of February, the FDA had identified five infants who became seriously ill with infections after they consumed the formula. Four had been infected with Cronobacter sakazakii  — an infrequent infection that can be deadly for babies — and one had been infected with salmonella. Two of the infected infants, from Ohio, died, according to the FDA.

Since then, the FDA has been working with Abbott to resolve the contamination issue.

The recall was particularly ill-timed given a U.S. shortage of powdered infant formula due to supply chain and labor issues. Even with the plant reopening, Abbott estimates those shortages could continue well into July.

"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.” said Robert B. Ford, chairman and CEO of Abbott, in  the company statement. 

“We look forward to working with the FDA to quickly and safely re-open the facility." 

Abbott has said it will take two weeks to relaunch production in Sturgis, with production of its medical formula lines launching first, before once again making Similac, the best-selling formula in the U.S.

From the time Abbott restarts the site, it will take six to eight weeks before its products are available on shelves, the company said.

Information on the consent agreement was not yet available from the FDA early Monday evening.

Abbott said it had been working with the FDA and making changes to its operation, including unidentified plant upgrades, since submitting an action plan on April 8.

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“Even before its formal response, Abbott had begun working to implement improvements and take corrective action,” the company said. 

The actions, it said, include reviewing and updating education, training and safety procedures for employees and visitors, and updating protocols regarding water, cleaning and maintenance procedures at the facility. 

Some members of Congress have been calling for an investigation into the factory contamination and the FDA’s promptness in responding to the issue. At the same time, the White House said it continues to look for solutions to the formula shortage, including boosting imports.

Meanwhile, FDA Commissioner Robert Califf said Monday during an appearance on the “Today” show that the agency will investigate its handling of the situation.

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