Michigan infant formula plant to restart production in June, company says
Infant formula maker Abbott said on Tuesday that its Sturgis, Michigan plant, where a recall helped fuel a national infant formula shortage, is set to reopen next month.
“Abbott plans to restart production at the Sturgis plant on June 4 and will prioritize production of EleCare, with the initial release of the EleCare product to consumers starting on or around June 20,” the company said. company in a press release.
The stimulus announcement came a week after the US Department of Justice confirmed a tentative agreement with Abbott to address safety issues at its plant, believed to be the nation’s largest infant formula manufacturing plant. .
Abbott’s recalled products included powdered formulas sold under the Similac, Alimentum and EleCare labels after four children fell ill with bacterial infections and two died. Several Abbott employees are accused of manufacturing the formula under conditions that failed to meet regulatory quality and safety standards, according to a federal court filing.
Last week, the DOJ said it had filed a legal complaint against Abbott for alleged quality and safety violations, and the company had already agreed to a proposed consent decree to address the issues.
After:Formula Shortage Hits Michigan Families, Especially the Poor
In its statement Tuesday, Abbott said the U.S. District Court for the Western District of Michigan amended the executive order allowing the company to release limited quantities of its EleCare specialty amino acid formulas that had been suspended after the reminder of February 17.
“The consent decree was amended at the request of Abbott and the U.S. Food and Drug Administration … to allow the company to offer EleCare to children in urgent medical need,” officials said. ‘Abbott. “These batches of EleCare products have been suspended pursuant to an agreement with the FDA. All products have been tested and meet all product release requirements.”
EleCare formulas are hypoallergenic and used by infants and children with severe food allergies or gastrointestinal disorders requiring amino acid-based formulas, the company said.
Abbott said it received clearance from regulators to release 300,000 cans of its specialty EleCare formula. The product was not part of the February recall.
“While Abbott has a limited stock of these products, there should be enough to meet current patient needs until a new product becomes available in the coming months,” the statement said. ‘Abbott.
Abbott said he plans to start shipping products “in the next few days” to healthcare professionals, hospitals or consumers.
“The immediate release of this product will help families affected by the lack of availability of EleCare,” said Robert B. Ford, president and CEO of Abbott. “When we restart our Sturgis plant the first week of June, we will produce EleCare first and manufacture enough to have several months’ supply available.”
Abbott’s recall in February of products made at the Sturgis plant exacerbated a nationwide shortage of infant formula caused by supply chain issues.
For three months, the Abbott plant in Sturgis has remained “voluntarily” closed, according to the FDA. The company said it was working to correct findings related to processes, procedures and conditions cited by FDA inspectors in March that raised concerns that powdered infant formula produced at the facility had a risk of contamination.
The FDA has announced new guidelines outlining increased flexibility for importing certain infant formulas to further increase their availability.
Michigan has temporarily expanded the types of formula eligible for assistance under the Women, Infants and Children program and notified people who have received state-recalled formula of the recommended next steps.
The White House said Abbott has agreed to continue paying rebates through August in states like Michigan, where the company holds the contract for the federal WIC program.
Last week, the Senate passed a bipartisan bill that would permanently relax regulations on which infant formula can be purchased under the federal low-income assistance program. This gives the U.S. Department of Agriculture more flexibility during a product recall, supply chain disruption, or other crisis so families aren’t limited by brand or type. of infant formula they can buy, according to a summary of the invoice.
The House also approved $28 million in emergency funding for the FDA to address the formula shortage.
Several congressional committees have held hearings to investigate the shortage.
The Federal Trade Commission announced Tuesday that it has launched an investigation, seeking information on any deceptive or fraudulent business practices related to it.
Meanwhile, the White House on Sunday announced the first two Defense Production Act clearances for infant formula, both from the Department of Health and Human Services.
Abbott Nutrition can now receive priority orders for raw materials such as sugar and corn syrup for infant formula, which the White House says will allow the manufacturer to quickly increase production by a third. Reckitt, owner of Mead-Johnson, can now receive priority orders for consumables such as filters and other single-use products needed to generate certain oils needed to produce infant formula, the White House said, which will allow Reckitt’s facilities to operate at maximum capacity.
The Biden administration has also begun airlifting shipments of infant formula from Europe. The first, a military plane carrying enough specialized infant formula for more than half a million baby bottles, arrived in Indianapolis on Sunday.