Abbott’s infant formula factory closed again due to flooding

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Abbott Nutrition has once again halted production at the Michigan plant that helped generate a shortage of infant formula across the country after storms hit the region and caused widespread flooding.

In a statement issued Wednesday afternoon, the company said it had stopped producing EleCare and other specialized and metabolic formulas after heavy storms on Monday caused power outages and caused flood damage in Sturgis, Mich. Abbott and the surrounding area, which restarted the Sturgis plant in less than two weeks. A few months ago, after a long-term shutdown, it helped trigger the crisis; he said heavy rains overwhelmed the city’s rainwater system, flooding parts of the city, “including areas of our plant.”

“As a result, Abbott has stopped production of its specialized EleCare formula that was underway to assess storm damage and clean and sanitize the plant,” the company said in a statement.

Abbott noted that he had informed the Food and Drug Administration of the closure of the factory, days after the agency signed its reopening, and that “it would conduct thorough testing together with the independent third party to ensure that the plant is safe. to resume production “. ”

“This is likely to delay the production and distribution of new products for a few weeks,” Abbott said.

The blame for the national shortage has fallen equally on Abbott and the FDA, with its commissioner, Robert M. Califf, saying that political leaders have taken the coals to various hearings in Congress in recent weeks.

On Thursday morning, at a Senate hearing on the pandemic, Sen. Patricia Murray (D-Wash.) Took a minute to ask Califf about the flood that forced Abbott’s infant formula manufacturing facility to Sturgis offline and what action the agency was taking in response. .

“We have intensive calls twice a day about all the work on the topic of infant formula,” Califf said. “And at the end of yesterday’s call I commented that it was one of the first days that we had not had any surprises. Twenty minutes later, the email crossed over the flood in Sturgis.

He assured parents and caregivers that the government is working to have enough product to meet current demand.

“We were hoping to have a super supply so we could completely replace the shelves. The estimate is maybe two weeks, but it’s too early to give an exact estimate of what the delay will be at the Sturgis plant,” he said. to say.

Abbott said the delay should not make the shortage worse because there was “ample supply in place,” and noted that it had produced £ 8.7 million in infant formula in June for the US, the equivalent of 168, 2 million 6 oz. feeds. A spokesman said it accounted for 95 per cent of Abbott’s production ahead of a February product recall and the closure of the Sturgis plant.

Abbott resumed production after meeting the requirements specified by a May FDA consent decree, which included, among other things, obtaining an independent expert to review operations and comply with the law.

“While this is an unfortunate setback and a reminder that natural weather events can also cause unforeseen supply chain disruptions, I want to reassure consumers that the work of the entire government to increase supply means we will have a product more than enough to meet current demand, “Califf tweeted Wednesday night. “We know that Abbott is working quickly to assess the damage and will report on its progress in the coming days. Once the company has a plan in place, the FDA will return to the facility working to make sure they can resume production of safe and quality formula products quickly “.

The closure comes about a week after recently released documents showed that the FDA had investigated reports that up to nine children had died since early 2021 after consuming infant formula produced at the Sturgis plant, seven more than the FDA had previously recognized.

New documents show more claims of infant formula illness and death

In all nine incidents, the agency was unable to identify the source of the infection. In some cases, there was not enough formula left to try. Of the babies who died of chronobacter infections, genomic sequencing revealed different strains than those discovered during an inspection this spring.

The factory closed earlier this year after an FDA inspection found allegedly unhealthy conditions. The factory produced most of Similac’s powder supply in the country and was the main producer of special formulas, so its closure greatly reduced supplies.

The company has previously said it expects the new production of EleCare, an amino acid-based formula for children with multiple allergies, to start reaching consumers next Monday or so.

But Abbott had also said it would take two weeks after receiving the green light from the FDA to reopen before production would resume completely, and another six to eight weeks to get the product on store shelves. This setback could delay the availability of EleCare for months.

Some websites sell EleCare infant formula for over $ 100 a can, and one site sells a six-pack for $ 628.

White House efforts to import formula to offset the domestic deficit have intensified, with nine flights scheduled for this week. On Sunday, the Department of Health and Human Services said in a statement, Operation Fly Formula flights will have imported about 12 million equivalents of 8-ounce bottles of infant formula, much of it special metabolic products for babies and people with allergic disorders.

Regular formula stocks remain low across the country, with store shelves about 77 percent full by the end of May. In the Upper Midwest, in particular, the rate of out-of-stock formulas remains high. Low-income Americans have been particularly hard hit, with food banks and other assistance programs reporting low supplies.

The FDA also announced steps Wednesday to bring 4.5 million pounds of formula-based powder from the Mead Johnson facility in Singapore to a Minnesota facility to increase production of Enfamil for newborns. The FDA estimates that this will produce about 5.7 million cans, the equivalent of about 66 million bottles, between July and November.

Abbott has not specified a date for the reopening of the plant due to this week’s floods.

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