Abbott has stopped production of EleCare formula in its Sturgis, Michigan, plant after severe storms led to flooding inside the plant, the company said, probably delaying production of new formula for a few weeks.
Production at the plant had restarted less than two weeks ago following a months-long closure that helped drive a nationwide formula shortage.
“Severe thunderstorms and heavy rains came through southwestern Michigan on Monday evening, resulting in high winds, hail, power outages and flood damage throughout the area,” Abbott said in a statement Wednesday night. “These torrential storms produced significant rainfall in a short period of time – overwhelming the city’s stormwater system in Sturgis, Mich., and resulting in flooding in parts of the city, including areas of our plant.
“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. We have informed FDA and will 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 that once the plant is re-sanitized and production resumes, it will restart EleCare production, followed by specialty and metabolic formulas, and it will “work to restart Similac production at the plant as soon as possible.”
In tweets Wednesday night, US Food and Drug Administration Commissioner Dr. Robert Califf said, “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 plant had been shut down for months after an FDA inspection that found Cronobacter sakazakii bacteria, which can be deadly to infants, in several areas. Similac, Alimentum and EleCare powdered infant formulas made at the plant were recalled, and the closure exacerbated shortages caused by supply chain disruptions. Families across the United States have struggled for months to find formula for infants and for people with specific nutrition needs.
Califf said last month that the shuttered Michigan plant needed extensive repairs, including replacing 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 in a kitchen next door if there was bacteria growing all over the place, and standing water and people tromping through with mud on their feet? Which is essentially what the inspection showed.”
In May, a federal judge signed off on an agreement between the FDA and Abbott that laid out the steps the company needed to take to restart production. The plant reopened June 4.
But on Monday, severe weather moved across the upper Midwest and the Ohio River Valley, including Michigan.
Califf called the latest closure an “unfortunate setback and a reminder that natural weather events can also cause unforeseen supply chain disruptions.”
Abbott said Wednesday that it has “ample existing supply of EleCare and most of its specialty and metabolic formulas” to meet the need until new products are available. Such products are being released to families through health care professionals.
There have also been moves to increase availability of other types of formula. President Joe Biden invoked the Defense Production Act to direct suppliers of formula ingredients to prioritize delivery to formula makers, and the administration launched Operation Fly Formula to import formula from abroad.
Califf said on Twitter on Wednesday that teams are working “night and day” to make formula available. He said Abbott has been exceeding the monthly quantity of formula produced in 2021 even while the Michigan facility was closed, and other producers are making formula at “higher-than-average rates.”
“This means that the total amount of formula available, even before the Sturgis plant is back in production, exceeds the demand for formula prior to the recall,” Califf wrote.
But many grocery store shelves remain bare. About a quarter of infant formula products were still out of stock in the United States last week, according to data from market research firm Information Resources Incorporated, or IRI.
IRI data is often cited by the White House as a measure of the severity of the shortage. The latest data shows that about 24% of infant formula products were out of stock during the week ending June 12, up from about 22% the week before.
Before a nationwide infant formula recall by Abbott in February, about 10% of infant formula products were typically out of stock.
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