“As a result, Abbott halted production of its EleCare specialty formula which was underway to assess storm damage and clean and sanitize the plant,” the company said in a statement.
Abbott noted that it notified the Food and Drug Administration of the plant’s closure — days after the agency approved its reopening — and that it “would conduct comprehensive testing in conjunction with the independent third party to ensure ensure the factory can safely resume production.”
“This will likely delay production and distribution of the new product by a few weeks,” Abbott said.
Blame for the national shortage fell roughly equally on Abbott and the FDA, its commissioner, Robert M. Califf, having been raked in by policymakers in several congressional hearings in recent weeks.
During a Senate hearing on the pandemic on Thursday morning, Sen. Patricia Murray (D-Wash.) took a minute to ask Califf about flooding that forced Abbott’s infant formula manufacturing plant to Sturgis offline and on the actions the agency was taking in response. .
“We have intensive calls twice a day on all the work on the infant formula issue,” Califf said. “And at the end of the call yesterday, I commented that it was one of the first days where we hadn’t had any surprises. Twenty minutes later, the email fell on the flooding in Sturgis.
He assured parents and carers that the government was working to have enough products to meet current demand.
“We were hoping to have a super supply in order to completely restock the shelves. The estimate may be two weeks, but it’s too early to give an exact estimate of what the delay at the Sturgis plant will be,” he said.
Abbott said the delay should not make the shortage worse because there was “sufficient supply”, noting that it produced 8.7 million pounds of infant formula in June for the United States, the equivalent of 168.2 million 6 oz. feedings. A spokesperson said that represented 95% of Abbott’s production before a product recall in February and the closure of the Sturgis plant.
Abbott resumed production after meeting requirements specified by a May consent decree with the FDA, which included obtaining an independent expert to review operations and compliance with the law, among other things.
“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. The work of all of government to increasing supply means we will have more than enough product to meet current demand.” Calif tweeted Wednesday night. “We know Abbott is working quickly to assess the damage and will update us on his progress in the coming days. Once the company establishes a plan, the FDA will be back at the facility to ensure it can quickly restart production of safe, quality formula products.
The shutdown comes about a week after newly released documents showed the FDA investigated reports that up to nine children had died since the start of 2021 after consuming infant formula produced at the Sturgis plant, seven more than previously recognized by the FDA.
New documents show more illness and death claims linked to infant formula
In all nine incidents, the agency was unable to identify the source of infection. In some cases, there was not enough formula left to test. Among the babies who died of cronobacter infections, genomic sequencing revealed different strains than those discovered during an inspection this spring.
The plant was closed earlier this year after an FDA inspection revealed allegedly unsanitary conditions. The plant produced most of the country’s supply of powdered Similac and was the main producer of specialty formulas, so its closure greatly reduced the supply.
The company previously said it expects new production of EleCare, an amino acid-based formula for children with multiple allergies, to start reaching consumers next Monday or around that time.
But Abbott had also said it would take two weeks after receiving the green light from the FDA to reopen before production fully resumes, and another six to eight weeks to get the product on store shelves. This setback could delay the availability of EleCare by several 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 infant formula to fill the domestic shortfall have intensified, with nine flights scheduled this week. The Department of Health and Human Services said in a statement on Sunday that Operation Fly Formula flights will have imported nearly 12 million 8-ounce bottle equivalents of infant formula, much of it product. special metabolic products for babies and people with allergic disorders.
Stocks of regular formula remain low nationwide, with store shelves about 77% full at the end of May. In the Upper Midwest in particular, the out-of-stock rate for formulas remains high. Low-income Americans have been hit particularly hard, with food banks and other assistance programs reporting low supplies.
The FDA also announced steps Wednesday to bring 4.5 million pounds of formula base powder from Mead Johnson’s Singapore plant to a Minnesota facility to ramp up production of Enfamil for newborns. The FDA estimates this will produce about 5.7 million cans, the equivalent of about 66 million bottles, between July and November.
Abbott did not specify a date for reopening the plant due to flooding this week.
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