Baby formula maker Abbott Labs says it has reached an agreement with the FDA to reopen its Sturgis, Michigan facility

WASHINGTON — Infant formula maker Abbott says it has reached an agreement with U.S. health officials to resume production at its largest domestic factory, a key step in alleviating a nationwide shortage linked to the plant’s closure earlier this year.

Abbott did not immediately detail the terms of the agreement it reached with the Food and Drug Administration, which has been investigating safety issues at the Sturgis, Michigan facility. The consent decree is a legally binding agreement between the company and the federal government.

Once production resumes, Abbott says it will take at least eight weeks to begin shipping new products to stores.

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

The Biden administration has come under intense pressure over the past week to do more to alleviate the infant formula shortage that has forced parents of infants to make significant efforts to feed their children.

Abbott’s plant came under scrutiny earlier this year after four infants contracted bacterial infections after consuming powdered formula from the Michigan factory. Two of the babies died.

In February, the company halted production and recalled several brands of milk formula. Those moves squeezed supplies already strained by supply chain disruptions and parental stockpiling during COVID-19.

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

Under fire from parents and politicians, President Joe Biden’s administration is expected Monday to announce an agreement to reopen the largest domestic infant formula manufacturing facility and relax import rules to allow shipments from overseas, amid a nationwide shortage caused by the factory Shutdown was triggered in Michigan earlier this year due to safety concerns.

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

It comes as the Biden administration has come under intense pressure over the past week to do more to alleviate the infant formula shortage that has forced parents of infants to make significant efforts to feed their children.

Over the weekend, the White House offered transportation and logistics support to formula makers and retailers and worked with all major formula makers to ramp up production, including contacting their suppliers to encourage them to prioritize the production and supply 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 demand and we stand ready to move assets in coordination with them as we identify needs.”

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

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

Califf said an announcement about importing baby formula from abroad is imminent, noting the key is making sure the instructions for the formula are in languages ​​mothers and carers can understand.

The FDA warned families against making their own baby formula because it contains 30 different ingredients that need to be in the right amounts or the formula could be potentially dangerous to consume.

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

Abbott is one of just four companies producing about 90% of its US formula, so the closure squeezed already tight supplies.

In March, after a six-week inspection, FDA investigators released a list of issues including lax safety and sanitation standards and a history of bacterial contamination in several parts of the facility.

However, Chicago-based Abbott has emphasized that its products have not been directly linked to bacterial infections in children. Samples of the bacteria found at his facility did not match strains collected from the babies by federal investigators. The company has repeatedly stated that it is ready to resume production pending an FDA decision.

The terms of the consent decree weren’t immediately clear, including steps Abbott was taking to address issues raised by the FDA, or how soon production at the plant would resume.

Former FDA officials say the types of problems uncovered at Abbott’s facility take time to correct and that infant formula facilities are subject to more scrutiny than other food facilities. Businesses must thoroughly clean facility and equipment, retrain staff, repeatedly test, and document that there is no contamination.

Even if the facility reopens soon, the FDA will continue to be scrutinized for its handling of the issues at the facility.

FDA inspectors visited the factory for a routine inspection in September, around the time the first bacterial infection was reported in an infant. Although inspectors uncovered multiple violations, including stagnant water and unsanitary conditions, the FDA did not close the facility or issue a formal warning.

It was only after several more illnesses were reported that the FDA returned to the facility in January, this time finding that a history of bacterial contamination had occurred in several parts of the facility. Abbott subsequently closed the facility and recalled several formula powders in mid-February.

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

She and other lawmakers will question FDA Commissioner Califf on the issue and others at a hearing scheduled for Thursday.

Copyright © 2022 by The Associated Press. All rights reserved. Baby formula maker Abbott Labs says it has reached an agreement with the FDA to reopen its Sturgis, Michigan facility

Chrissy Callahan

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