“As a result, Abbott has discontinued production of its specialized EleCare formula that was in progress to assess storm damage and clean and re-sterilize the plant. We have notified the FDA and will conduct comprehensive testing in conjunction with the independent third party in order to ensure that the plant is It is safe to resume production. This will likely delay the production and distribution of a new product by a few weeks.”
Once the plant is re-sterilized and production resumes, Abbott said he will restart production of EleCare, followed by specialty formulas and metabolites, and “will work to restart Similac production at the plant as soon as possible.”
The factory has been closed for months
The plant was closed for months after a Food and Drug Administration (FDA) examination found Cronobacter sakazakii, which can be fatal to infants, in several areas. Factory-made Similac, Alimentum and EleCare infant formulas have been recalled, and the shutdown has 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 nutritional needs.
Califf said last month that the closed Michigan plant needed extensive repairs, including replacing the roof and floors.
“You can’t open a plant that has bacteria growing on it,” he said during a Senate committee hearing. “I mean, would you go into the kitchen next door if there was bacteria growing everywhere, standing water and people getting mud on their feet? Which is basically what the scan showed.”
In May, a federal judge signed an agreement between the Food and Drug Administration and Abbott, which outlined the steps the company would need to take to resume production. The factory reopened on June 4th.
But on Monday, the severe weather moved across the upper Midwest and the Ohio River Valley, including Michigan.
Califf called the recent shutdown “an unfortunate setback and a reminder that normal weather events can also cause unexpected disruptions to the supply chain.”
Working “day and night” to supply formula milk
Abbott said Wednesday that it has a “current ample supply of EleCare and most specialty formulas and metabolites” to meet the need for new products to become available. These products are released to families by healthcare professionals.
There have also been moves to increase the availability of other types of equations. President Joe Biden invoked the Defense Production Act to direct formula ingredient suppliers to prioritize delivery to formula makers, and the administration launched the Fly Formula process to import formula from abroad.
Califf said on Twitter on Wednesday that teams were working “day and night” to make the formula available. He said Abbott exceeded the monthly amount of formula produced in 2021 even while the Michigan facility was closed, and other producers were making the formula “at above-average rates.”
“This means that the total amount of formula available, even before Sturgis plant production returns, exceeds the demand for formula prior to recall,” Califf wrote.
But many grocery store shelves remain bare. Nearly a quarter of infant formula products were still unavailable 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 deficiency severity. 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 Abbott’s nationwide recall of infant formula in February, about 10% of infant formula products were out of stock.
CNN’s Deidre MacPhillips contributed to this report.