As the US struggles to recover from a dire infant formula shortage, Abbott’s infant formula factory, which is at the heart of the crisis, has been shut down again – this time due to flooding from heavy rain on Monday.
The Sturgis, Michigan facility is the largest formulary facility in the United States and is operated by Abbott, one of the largest formularies in the county. The facility had previously closed in February, which had brought a nationwide shortage of infant and specialty foods to a critical point, but was able to reopen on June 4.
The February closure came as the Food and Drug Administration was investigating serious bacterial infections in four infants, two of whom died. All of the infants had been ingesting infant formula made from the plant, and FDA investigators found that the same type of bacteria infected the infants –Cronobacter sakazakii– also lurked in several areas of the facility. Although the data for each case of the infants was limited, at least one container of formula from the plant tested positive for the strain of Cronobacter sakazakii infect one of the babies.
In a hearing before Congress last month, FDA Commissioner Robert Califf testified that the conditions at the facility “tremendously unhygienic‘ and told lawmakers that ‘frankly, the inspection results were shocking’.
Also in May, Abbott and the FDA entered into a consent order requiring Abbott to hire an independent expert to review operations and ensure compliance with the law. The company is also committed to maintaining product testing standards and implementing a hygiene plan, environmental monitoring plan and employee training programs. Overall, the consent decree laid out the steps Abbott needed to take to reopen, which it did earlier this month.
The facility resumed operations by resuming production of EleCare and other specialty and metabolic formulas, the first batches of which Abbott said could reach consumers by around June 20.
But after only 11 days of operation, the system is now being shut down again. in the a statement Wednesdaythe company said heavy rain Monday night overwhelmed Sturgis’ stormwater system, causing flooding at the facility and other parts of the city.
“As a result, Abbott has halted production of its EleCare specialty formula, which was underway to assess the damage caused by the storm and to clean and re-sanitize the facility,” the company said. “We have notified the FDA and will be conducting extensive testing with the independent third party to ensure the facility can safely resume production. This will likely delay production and distribution of new products by a few weeks.”
The company added that it “has an adequate supply of EleCare and most of its specialty and metabolic formulas to meet needs for these products until a new product becomes available.”
in the Late night tweets Wednesday, FDA’s Califf said he spoke with Abbott’s CEO and said the plant’s closure was “an unfortunate setback and a reminder that natural weather events can also result in unforeseen supply chain disruptions.” However, he went on to say that “the effort across the government to increase supply means we will have more than enough product to meet current demand.”
However, many parents may still be faced with sparse or empty shelves. According to market research firm Information Resources Incorporated (IRI) reported by CNNData for the week ending June 12 found about 24 percent of infant formula products sold out, up from about 22 percent the week before.
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