Abbott and the FDA have reached an agreement to reopen the company’s largest baby formula plant in the U.S. amid a nationwide shortage. It will still be another six to eight weeks before formula made in the plan hits shelves. Meanwhile, at least half of baby formula in the country is out of stock.
“Our No. 1 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,” said Robert B. Ford, chairman and chief executive officer of Abbott.
The Sturgis, Mich., baby formula plant shut down in February and several brands were recalled after two babies died and two others were sick with bacterial infections after consuming formula made there. A subsequent FDA investigation found lax safety and cleaning standards. Abbott countered that samples of bacteria at the plant were different from the bacteria that infected the babies. Still, the plant had to shutter until the whole facility was cleaned, staff retrained, and testing done to ensure safety.
Abbott is one of four companies that account for about 90% of the domestic production of baby formula. FDA commissioner Robert Califf told ABC News that that the administration is working on importing formula. Only 2% of the formula used in the U.S. is imported, and there is normally a lengthy FDA approval process for imported formulas.
Abbott announced Friday it was importing product from its Cootehill, Ireland, baby formula plant for the federal government’s Women, Infants and Children (WIC) low-income program.
As with so many goods, there were already supply chain issues delaying baby formula production before Abbott’s largest domestic manufacturing facility shut for three months.