Deal reached with FDA to reopen Michigan infant formula plant

Baby formula manufacturer Abbott and the Food and Drug Administration agreed Monday on a consent decree outlining the steps necessary to resume production at the company’s Sturgis, Mich., plant, which shut down due to safety issues earlier this year.

The decree, which mandates the specific measures the company must take to increase safety and ensure compliance with federal law, needs court approval to move forward.

“Parents who feed their babies formula must have confidence these products are safe,” U.S. Atty. Mark Totten for the Western District of Michigan said in a statement. “This proposed consent decree aims to protect one of our most vulnerable populations.”

Once the FDA determines that the steps necessary to restart the plant have been met, Abbott could resume production at the site within two weeks. It would take an additional six to eight weeks before the formula produced would be available on shelves.

According to an Abbott news release, the facility would first focus on producing the hypoallergenic formulas EleCare, Alimentum and metabolic formulas first, and then begin production of Similac and other formulas.

The company will also continue to import formula from an FDA-registered facility in Ireland to help alleviate near-term supply shortage, according to the release.

“Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward reopening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely reopen the facility,” Robert B. Ford, Abbott’s chairman and chief executive, said in a statement. “We know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage.”

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