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Baby formula maker Abbott Labs says agreement reached with FDA to reopen Sturgis, Michigan facility

WASHINGTON — Infant formula maker Abbott said it has reached an agreement with U.S. health officials to restart production at its largest nationwide plant, a key step to easing a nationwide shortage related to the plant’s closure earlier this year. year.

Abbott did not immediately detail the terms of the agreement with the Food and Drug Administration, which has been investigating safety issues at the Sturgis, Michigan, plant. 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 products to stores.

Note: The video in the player above is from a related report.

The Biden administration has come under intense pressure over the past week to do more to ease the shortage of infant formula that has forced parents of infants to go to great lengths to feed their children.

The Abbott factory came under intense scrutiny earlier this year after four infants fell ill with bacterial infections after consuming formula from the Michigan factory. Two of the babies died.

In February, the company halted production and recalled several brands of infant formula. These steps reduced supplies that were already strained by supply chain disruptions and parent stockpiling during COVID-19.

THIS IS A BREAKING NEWS UPDATE. AP’s previous story follows below.

WASHINGTON (AP) — Under fire from parents and politicians, President Joe Biden’s administration is expected to announce an agreement on Monday to reopen the nation’s largest infant formula manufacturing plant and ease import rules to allow the supply from overseas, amid a national shortage spurred by the Michigan plant closing earlier this year for safety reasons.

A consent decree between the producer, Abbott, and the Food and Drug Administration that would pave the way for the plant to reopen is “coming soon,” said Brian Deese, director of the White House National Economic Council. He added that the agency would also take steps on Monday to allow more foreign imports into the United States to address urgent supply constraints.

It comes as the Biden administration has come under intense pressure over the past week to do more to ease the shortage of infant formula that has forced parents of infants to go to great lengths to feed their children.

Over the weekend, the White House offered formula makers and retailers transportation and logistical support, and worked with all major formula producers to boost production, including contacting their suppliers to encourage them to prioritize the production and delivery of formula ingredients.

Deese said the administration “has made it clear to everyone that federal resources, including transportation and logistics resources, are available and on call and that we stand ready to move assets in coordination with them as we go.” as we identify the needs”.

The shortage stems from a February recall by Abbott, the nation’s largest formula maker, which closed the company’s Michigan plant and exacerbated ongoing supply chain disruptions among formula makers, leaving fewer options on store shelves in much of the country. The shortage has led retailers like CVS and Target to limit the number of containers customers can buy per visit and has forced some parents to trade and sell formula online.

On Monday, FDA Commissioner Robert Califf told ABC News’ “Good Morning America” ​​that the federal agency is “working very closely with Abbott” to reopen the closed Michigan plant and he expects that “in a very short time, we’re going to have an announcement on the way forward.”

Califf said an announcement is forthcoming regarding the importation of infant formula from overseas, noting that the key is to ensure instructions for formula are in languages ​​that mothers and carers can understand .

The FDA has warned families against making their own formula because it contains 30 separate components that must be in the correct amount or the formula can be unsafe to consume.

Abbott’s voluntary recall was triggered by four reported illnesses in babies who had consumed powdered formula from the Michigan plant. All four infants were hospitalized with a rare type of bacterial infection and two died.

Abbott is one of only four companies that produce around 90% of the US formula, so its closure has cut into already tight supplies.

After a six-week inspection, FDA investigators released a list of issues in March, including lax safety and health standards and a history of bacterial contamination in several parts of the plant.

But Chicago-based Abbott stressed that its products were not directly linked to bacterial infections in children. The bacteria samples found at his factory did not match the strains taken from the babies by federal investigators. The company has repeatedly said it is ready to resume manufacturing, pending an FDA decision.

The terms of the consent decree were not immediately clear, including what steps Abbott was taking to address issues raised by the FDA or how quickly production at the plant would be restarted.

Former FDA officials say fixing the kind of problems found at Abbott’s plant takes time, and infant formula facilities face more scrutiny than other food facilities. Companies must thoroughly clean the facility and equipment, retrain personnel, test repeatedly, and document that there is no contamination.

Even if the facility reopens soon, the FDA will still come under scrutiny for its handling of issues at the plant.

FDA inspectors visited the plant in September for a routine inspection, around the time the first bacterial infection was reported in an infant. Although inspectors found several violations, including standing water and unsanitary conditions, the FDA did not shut down the plant or issue a formal warning.

It was only after several other illnesses were reported that the FDA returned to the plant in January, this time finding a history of bacterial contamination in several parts of the plant. Abbott then closed the plant and recalled several powdered formulas in mid-February.

Congresswoman Rosa DeLauro reported last month that a whistleblower contacted the FDA in October about unsafe conditions and practices at the plant, including falsifying plant records and failing to Properly test the formula for contamination.

She and other lawmakers are expected to question FDA Commissioner Califf on this and other issues at a hearing scheduled for Thursday.

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