Production at the plant resumed less than two weeks ago after a month-long shutdown that helped cause a nationwide formula shortage, causing damage across the region,” Abbott said in a statement Wednesday night. “These torrential storms resulted in a short Time for significant rainfall – it flooded the city’s stormwater system in Sturgis, Michigan and caused flooding in parts of the city, including areas of our facility.
“As a result, Abbott has halted production of its EleCare specialty formula, which was underway to assess the damage caused by the storm and clean and re-sanitize the facility. We have notified the FDA and will be conducting extensive testing along with the independent third party to ensure the facility is safe to resume production. This will likely delay production and distribution of new products by a few weeks.”
Abbott said once the facility is sanitized again and production resumes, it will resume EleCare production, followed by specialty and metabolic formulas, and will “work to get Similac production back at the facility as soon as possible.” record”.
in the tweets Wednesday evening said Dr. Robert Califf, Commissioner of the US Food and Drug Administration: “We know that 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 be back at the facility working to ensure they can quickly resume production of safe, high-quality formula products.”
Factory closed for months
The facility was shut down for months after an FDA inspection found several areas infected with Cronobacter sakazakii bacteria, which can be fatal to infants. Plant-made powdered infant formulas from Similac, Alimentum and EleCare 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 people with special diets.
Califf said last month that the closed Michigan plant required major repairs, including replacing the roof and floors.
“You just can’t open a factory that grows bacteria,” he said during a Senate committee hearing. “I mean, would you walk into a kitchen next door if there was bacteria growing everywhere and water standing and people stomping through with mud on their feet? That is essentially what the inspection found.”
In May, a federal judge signed an agreement between the FDA and Abbott outlining the steps the company needed to take to resume production. The plant reopened on June 4th.
But on Monday, severe weather swept across the upper Midwest and the Ohio River Valley, including Michigan.
Califf called the recent closure an “unfortunate setback and a reminder that natural weather events can also cause unforeseen supply chain disruptions.”
Work “day and night” on the supply of milk food
Abbott said Wednesday it has “a large inventory of EleCare and most of its specialty and metabolic formulas” to meet demand until new products become available. Such products are made available to families by health professionals.
Steps have also been taken to increase the availability of other types of formulas. President Joe Biden invoked the Defense Manufacturing Act to direct formula ingredient suppliers to prioritize delivery to formula manufacturers, and the government launched Operation Fly Formula to import formula from abroad.
Califf said on Twitter on Wednesday that teams are working “day and night” to make the formula available. He said Abbott exceeded the monthly amount of formulas produced in 2021 even when the Michigan facility was closed, and other manufacturers were making formulas at “above average rates.”
“This means that the total amount of formula available before the Sturgis plant goes back into production will exceed the demand for formula before the recall,” Califf wrote.
But many supermarket shelves remain empty. About a quarter of infant formula products in the United States were sold out last week, according to data from market research firm Information Resources Incorporated (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 sold out in the week ended June 12, up from about 22% the week before.
Prior to Abbott’s nationwide infant formula recall in February, about 10% of infant formula products were typically out of stock.
CNN’s Deidre McPhillips contributed to this report.