Production at the plant resumed less than two weeks ago after a month-long closure, which helped address a shortage of formula across the country. ” Hail, power outages and flood damage throughout the area, Abbott said in a statement Wednesday night. floods in parts of the city, including areas of our headquarters.
“As a result, Abbott stopped production of its special EleCare formula, which was underway to assess the damage caused by the storm and to clean and re-rehabilitate the plant. We have informed the FDA and will conduct a thorough test with an independent third party to ensure that the plant is safe to resume production. This will probably slow down the production and distribution of the new product for a few weeks. “
Abbott said that once the plant is rehabilitated and production resumed, it will restart production of EleCare, followed by special and metabolic formulas, and will “work to restart Similac’s production at the plant as soon as possible”.
In tweets Wednesday night, U.S. Food and Drug Administration commissioner Dr. Robert Calif said: “We know Abbott is working quickly to assess the damage and will report back to us in the coming days. Once the company has established a plan, the FDA will return to the facility to work to ensure it can quickly resume production of safe and quality formula products. “
The plant has been closed for months
The plant was closed for months after an FDA inspection found the bacterium Cronobacter sakazakii, which can be deadly to infants, in several areas. Similac, Alimentum and EleCare powdered infant formulas produced at the factory were withdrawn and the closure exacerbated the shortage caused by supply chain disruptions. Families in the United States have been struggling for months to find formula for infants and people with special nutritional needs.
Caliph said last month that the closed plant in Michigan needed extensive repairs, including replacement of the roof and floors.
“You just can’t open a plant with bacteria growing in it,” he said during a Senate committee hearing. “I mean, would you go to a kitchen next door if there were bacteria everywhere, stagnant water, and people trampling mud on their feet?” Which, in essence, the inspection showed. “
In May, a federal judge signed an agreement between the FDA and Abbott outlining the steps the company must take to restart proceedings. The plant opened on June 4.
But heavy weather on Monday moved to the upper Midwest and the Ohio River Valley, including Michigan.
Caliph called the recent closure an “unfortunate failure and a reminder that natural weather events can also cause unforeseen disruptions in the supply chain.”
Work night and day on the supply of formula
Abbott said Wednesday that it has “enough existing supplies of EleCare and most of its special and metabolic formulas” to meet the need until new products are available. Such products are released to families through health professionals.
There are also steps to increase the availability of other types of formulas. President Joe Biden cited the Defense Manufacturing Act to direct formula ingredient suppliers to prioritize delivery to formula manufacturers, and the administration launched Operation Fly Formula to import formula from abroad.
Caliph said on Twitter Wednesday that teams are working “night and day” to make the formula available. He said Abbott exceeded the monthly amount of formula produced in 2021, even when the Michigan plant was closed and other producers were making a formula with “higher than average prices”.
“This means that the total amount of formula available, even before the Sturgis plant is back in production, exceeds the demand for formula before withdrawal,” Calif wrote.
But many grocery store shelves remain bare. About a quarter of infant products were not yet in stock in the United States last week, according to market research firm Information Resources Incorporated or IRI.
IRI data are often cited by the White House as a measure of the severity of the shortage. Recent data show that about 24% of infant products were depleted in the week ending June 12, compared to about 22% the previous week.
Prior to the seizure of infant food across the country from Abbott in February, about 10% of infant products were usually out of stock.
CNN’s Deidre McPhillips contributed to this report.
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