“As a result, Abbott has halted production of its EleCare specialty formula, which was in the process of assessing damage caused by the storm and cleaning and refurbishing the facility,” the company said in a statement.
Abbott noted that it had informed the Food and Drug Administration of the plant closure – days after the agency signed the reopening – and that it would “conduct extensive testing in collaboration with the independent third party to ensure the plant is safe to resume production.”
“This is likely to delay the production and distribution of new product for a few weeks,” Abbott said.
The blame for the national shortage has fallen fairly similarly on Abbott and the FDA, with its commissioner, Robert M. Califf, who has been torn over the coals by politicians in several congressional hearings in recent weeks.
On Thursday morning, in a Senate hearing on the pandemic, Senator Patricia Murray (D-Wash.) Spent a minute asking Califf about the flood that forced Abbott’s breastfeeding facility in Sturgis offline, and what measures the agency took in response. .
“We have intensive discussions twice a day about all the work on the breast milk substitute issue,” Califf said. “And at the end of the conversation yesterday, I commented that it was one of the first days we had not had any surprises. Twenty minutes later came the email 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 in stock. The estimate is perhaps two weeks, but it is 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 exacerbate the shortage because it was “abundantly existing supply”, noting that it had produced £ 8.7 million in infant formula in June for the United States, equivalent to 168.2 million 6 oz. feeds. A spokesman said that this 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 the requirements specified in a May Decree Decree with the FDA, which included having an independent expert review the operation and compliance with the law.
“While this is an unfortunate setback and a reminder that natural weather events can also cause unforeseen disruptions in the supply chain, I want to assure consumers that all government efforts to increase supply mean we will have more than enough products to meet today’s demand. . “Califf twitret Wednesday evening. “We know that Abbott is working quickly to assess the damage and will report progress to us in the coming days. Once the company has established a plan, the FDA will be back in the facility and working to ensure that they can quickly begin producing safe formula products. high quality.
The closure comes about a week after recently released documents showed that the FDA had examined reports that as many as nine children had died since early 2021 after consuming baby substitutes produced at the Sturgis plant – seven more than previously recognized by the FDA.
New documents show several allegations of infantile disease and death
In all nine incidents, the agency was unable to identify the source of the infection. In some cases, there were not enough residues of the formula to test. Of the babies who died of Cronobacter infections, genomic sequencing showed strains other than those discovered during an inspection this spring.
The factory was closed earlier this year after an FDA inspection revealed allegedly unhygienic conditions. The factory produced most of the country’s supply of powdered Similac and was the main producer of specialty formulas, so the closure greatly reduced supplies.
The company has previously said it expects 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 had also said it would take two weeks after receiving the green light from the FDA to reopen before production would resume in full, and another six to eight weeks to get the product on store shelves. This setback could delay the availability of EleCare by months.
Some sites sell EleCare infant formula for more than $ 100 per box, and one site sells a six-pack for $ 628.
The White House’s efforts to import formula to compensate for the domestic deficit have escalated, with nine flights scheduled 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 the usual formula remain low on a national basis, with store shelves at around 77 per cent full by the end of May. Especially in the upper Midwest, the proportion of sold-out formulas is still high. Low-income Americans have been particularly hard hit, with food banks and other utilities reporting low supplies.
The FDA also announced measures on Wednesday to bring 4.5 million pounds of formula base powder from Mead Johnson’s Singapore facility to a facility in Minnesota to increase production of Enfamil for newborns. The FDA estimates that this will produce around 5.7 million cans, equivalent to around 66 million bottles, between July and November.
Abbott has not specified a date for reopening the facility due to this week’s flood.