“As a result, Abbott has stopped production of its EleCare specialty formula that was underway to assess damage caused by the storm and clean and re-sanitize the plant,” the company said in a statement.
Abbott noted it had informed the Food and Drug Administration of the factory closure — days after the agency signed off on its reopening — and that it would “conduct comprehensive testing in conjunction with the independent third party to ensure the plant is safe to resume production.”
“This will likely delay production and distribution of new product for a few weeks,” Abbott said.
Blame for the national shortage has fallen fairly equally on Abbott and the FDA, with its commissioner, Robert M. Califf, getting raked over the coals by policymakers in several congressional hearings in recent weeks..
On Thursday morning, in a Senate hearing about the pandemic, Sen. Patricia Murray (D-Wash.) took a minute to ask Califf about the flooding that forced Abbott’s infant formula manufacturing facility in Sturgis offline and what action the agency was taking in response.
“We have twice-daily intensive calls about all the work on the infant formula issue,” Califf said. “And at the end of the call yesterday, I commented it was one of the first days that we hadn’t had any surprises. Twenty minutes later, the email came cross about the flood in Sturgis.”
He assured parents and caregivers that the government is working to have sufficient product to meet current demand.
“We had hoped to have a super supply so that we get the shelves completely restocked. The estimate is perhaps two weeks, but it’s too early to give an exact estimate of what the delay will be in the Sturgis plant,” he said.
Abbott said the delay should not worsen the shortage because there was “ample existing supply,” noting that it had produced 8.7 million pounds of infant formula in June for the U.S., the equivalent of 168.2 million 6 oz. feedings. A spokesperson said that represented 95 percent of Abbott’s output before a February product recall and the Sturgis plant closure.
Abbott resumed production after meeting requirements specified by a May consent decree with the FDA, which included, among other things, obtaining an independent expert to review operations and compliance 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 the all-of-government work to increase supply means we’ll have more than enough product to meet current demand,” Califf tweeted on Wednesday night. “We know Abbott is working quickly to assess the damage and will be reporting its progress to us in the days ahead. Once the company establishes a plan, FDA will be back in the facility working to ensure that they can restart producing safe and quality formula products quickly.”
The closure comes about a week after newly released documents showed the FDA had investigated reports that as many as nine children had died since early 2021 after consuming baby formula produced at the Sturgis plant — seven more than previously acknowledged by the FDA.
In all nine incidents, the agency was unable to identify the source of the infection. In some cases, there was not enough leftover formula to test. Of the babies who died of cronobacter infections, genomic sequencing turned up different strains than what was discovered during an inspection this spring.
The factory was closed earlier this year after an FDA inspection turned up allegedly unsanitary conditions. The factory produced most of the country’s supply of powdered Similac and was the main producer of specialty formulas, so its closure severely curtailed supplies.
The company has said previously that it expected new production of EleCare, an amino acid-based formula for children with multiple allergies, to begin reaching consumers on or about next Monday.
But Abbott also had said it would take two weeks after receiving the greenlight from the FDA to reopen before production would fully resume, and another six to eight weeks to get product on store shelves. This setback could delay the availability of EleCare by months.
The White House’s efforts to import formula to make up for the domestic shortfall have stepped up, with nine flights scheduled for this week. By Sunday, the Department of Health and Human Services said in a statement, Operation Fly Formula flights will have imported nearly 12 million 8-ounce bottle equivalents of infant formula, much of it special metabolic products for babies and individuals with allergic disorders.
Stocks of regular formula remain low nationwide, with store shelves at 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 hit especially 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 facility to a facility in Minnesota to step 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 has not specified a date for reopening the plant due to this week’s flooding.
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