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Abbott Nutrition has once again halted production at its Michigan plant, which has caused a nationwide baby food shortage after storms battered the region and caused widespread flooding.
In a statement released late Wednesday, the company said it halted production of EleCare and other specialty and metabolic formulas after severe thunderstorms Monday triggered power outages and flood damage in and around Sturgis, Mich. Abbott – who restarted the Sturgis plant in less than two weeks after a months-long shutdown helped spark the crisis – said heavy rain overwhelmed the city’s stormwater system and flooded parts of the city, ” including areas of our factory”.
“As a result, Abbott has halted production of its EleCare specialty formula, which was underway to assess the damage caused by the storm and to clean and re-sanitize the facility,” the company said in a statement.
Abbott noted that it had notified the Food and Drug Administration of the facility’s closure — days after the agency signed off on the reopening — and that it “will be conducting extensive testing, along with the independent third party, to ensure the facility can safely resume.” can. ”
“This will likely delay production and distribution of new products by a few weeks,” Abbott said.
Blame for the nationwide shortage rests equally with Abbott and the FDA, with Commissioner Robert M. Califf, who have been raked over the coals by policymakers in several congressional hearings over the past few weeks.
On Thursday morning, in a Senate hearing on 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 the Actions taken by the Agency in response.
“We have intense twice-daily calls about all the infant formula work,” Califf said. “And at the end of yesterday’s conversation, I noticed that this was one of the first days that we hadn’t had any surprises. Twenty minutes later came the email about the flood in Sturgis.
He assured parents and carers that the government is working to have enough products to meet current demand.
“We had hoped for a super supply so that we could have the shelves completely stocked. The estimate is maybe two weeks, but it’s too early to give an accurate estimate of the delay at the Sturgis plant,” he said.
Abbott said the delay shouldn’t make the shortage worse because there are “ample supplies,” noting that 8.7 million pounds of infant formula for the US were produced in June, equivalent to 168.2 million 6 ounces. feedings. A spokesman said it represented 95 percent of Abbott’s production before a product recall in February and the closure of the Sturgis plant.
Abbott resumed production after meeting requirements set out in a May compliance writ with the FDA, which included hiring an independent expert to review operations and compliance.
“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 efforts across Government to increase supply mean we will have more than enough product to meet current demand,” Kaliff tweeted on Wednesday evening. “We know Abbott is working quickly to assess the damage and will update us on its progress in the coming days. Once the company has a plan in place, the FDA will return to work at the facility to ensure they can quickly resume production of safe, high-quality formula products.”
The closure comes about a week after newly released documents showed the FDA was investigating reports that up to nine children had died after consuming baby formula made at the Sturgis plant since early 2021 — seven more than previously recognized by the FDA.
New documents show more claims of sickness and death from baby food
In all nine incidents, the authority could not identify the source of infection. In some cases, there was not enough leftover formula to test. In the babies who died from Cronobacter infections, genome sequencing revealed different strains than those discovered during an inspection this spring.
The factory was shut down earlier this year after an FDA inspection allegedly found unsanitary conditions. The factory produced most of the country’s supply of powdered Similac and was the main producer of specialty formulations, so its closure severely curtailed supplies.
The company has previously said it expects new production of EleCare, an amino acid-based formula for children with multiple allergies, to reach consumers on or about next Monday.
But Abbott had also said it would take two weeks after the FDA gave the green light to reopen before production would fully resume and another six to eight weeks to get the product on shelves. This setback could delay the availability of EleCare by months.
Some sites sell EleCare infant formula for more than $100 a can, and one site sells a six-pack for $628.
Efforts by the White House to import formula to help make up the domestic deficit have intensified, with nine flights scheduled for this week. By Sunday, the Department of Health and Human Services said in a statement that Operation Fly Formula flights will have imported nearly 12 million 8-ounce bottle-equivalent infant formulas, many of them special metabolites for babies and those with allergic conditions.
Regular formula inventories remain low across the country, with store shelves about 77 percent full by the end of May. In the upper Midwest in particular, out-of-print formula rates remain high. Low-income Americans have been hit particularly hard, as food banks and other relief programs report low supplies.
The FDA also announced moves on Wednesday to move 4.5 million pounds of formula base powder from Mead Johnson’s Singapore facility to a Minnesota facility to ramp up production of Enfamil for newborns. The FDA estimates this will produce about 5.7 million doses between July and November, which translates to about 66 million bottles.
Abbott has not given a date when the plant will reopen due to this week’s flooding.