As the US struggles to recover from a dire infant formula shortage, the Abbott formula plant at the center of the crisis has again shut down—this time due to flooding from heavy rain on Monday.
The plant in Sturgis, Michigan, is the largest formula factory in the US and is operated by Abbott, one of the largest formula manufacturers in the county. The facility had previously shut down in February, driving a nationwide shortage of infant and specialty formulas to a critical point, but had managed to reopen on June 4.
The February closure occurred as the Food and Drug Administration investigated severe bacterial infections in four infants, two of whom died. All of the infants had consumed formula from the plant, and FDA investigators found that the same kind of bacteria infecting the infants—Cronobacter sakazakii—was also lurking in multiple areas of the plant. Although data was limited on each of the infants’ cases, at least one container of formula from the plant tested positive for the strain of Cronobacter sakazakii infecting one of the infants.
In a congressional hearing last month, FDA Commissioner Robert Califf testified that the conditions at the plant were “egregiously unsanitaryand told lawmakers that “frankly, the inspection results were shocking.”
Also in May, Abbott and the FDA entered a consent decree that required Abbott to retain an independent expert to review operations and ensure compliance with the law. The company is also mandated to uphold product testing standards and implement a sanitation plan, an environmental monitoring plan, and employee training programs. Overall, the consent decree laid out the steps that Abbott needed to take to reopen, which it did earlier this month.
The plant summarized operations by restarting production of EleCare and other specialty and metabolic formulas, initial batches of which could reach consumers by around June 20, according to Abbott.
But after being open for just 11 days, the plant is now shut down again. In a statement Wednesdaythe company said that heavy rains Monday evening overwhelmed Sturgis’ stormwater system, causing flooding in the plant and other parts of the city.
“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,” the company said. “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.”
The company added that it “has ample existing supply of EleCare and most of its specialty and metabolic formulas to meet needs for these products until new product is available.”
In late-night tweets Wednesday, FDA’s Califf said he had spoken with Abbott’s CEO and called the plant’s closure “an unfortunate setback and a reminder that natural weather events can also cause unforeseen supply chain disruptions.” However, he went on to say that “the all-of-government work to increase supply means we’ll have more than enough product to meet current demand.”
But, many parents may still be facing sparse or bare shelves. According to data from market research firm Information Resources Incorporated (IRI), reported by CNNdata from the week ending on June 12 found that about 24 percent of infant formula products were out of stock, up from about 22 percent the week before.