As the US struggles to recover from a dire infant formula shortage, the Abbott factory at the center of the crisis has once again closed – this time due to flooding from heavy rain on Monday.
The Sturgis, Michigan plant is the largest formula plant in the US and is operated by Abbott, one of the largest formula manufacturers in the province. The facility had previously closed in February, pushing a nationwide shortage of infant and specialty formulas to a critical point, but had managed to reopen on June 4.
The February shutdown came as the Food and Drug Administration investigated serious bacterial infections in four babies, two of whom died. All the babies had consumed formula from the plant, and FDA researchers found that the same kind of bacteria that infected the babies…Cronobacter sakazakii– also lurked in multiple parts of the plant. While data on each of the infants’ cases was limited, at least one bottle of plant formula tested positive for the strain of Cronobacter sakazakii infect one of the babies.
In a congressional hearing last month, FDA Commissioner Robert Califf testified that conditions at the plant were “extremely unsanitary” and told lawmakers that “frankly, the inspection results were shocking.”
Also in May, Abbott and the FDA entered into a clearance decision requiring Abbott to hire an independent expert to review its activities and ensure legal compliance. The company is also mandated to maintain product testing standards and implement a sanitation plan, environmental monitoring plan and employee training programs. Overall, the consent decree laid down the steps Abbott needed to take to reopen, which it did earlier this month.
“Unfortunate setback”
The plant resumed operations by restarting production of EleCare and other specialty and metabolic formulas, the first batches of which could reach consumers around June 20, Abbott said.
But after only being open for 11 days, the factory has now shut down again. In a statement released Wednesday, the company said heavy rains flooded Sturgis’ stormwater system Monday evening, causing flooding in the factory and other parts of the city.
“As a result, Abbott has halted production of its EleCare specialty formula that was underway to assess damage caused by the storm and to clean and re-decontaminate the plant,” the company said. “We have notified the FDA and will conduct extensive 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 products for a few weeks.”
The company added that it has “ample existing stock of EleCare and most of its specialty and metabolic formulas to meet the needs of these products until a new product is available.”
In nightly tweets WednesdayFDA’s Califf said he had spoken with Abbott’s CEO, calling 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 entire government’s work to increase supply means we will have more than enough product to meet current demand.”
But many parents may still be dealing with sparse or bare shelves. According to data from market research firm Information Resources Incorporated (IRI), reported by CNN, data from the week ending June 12 showed that about 24 percent of infant formula products were out of stock, up from about 22 percent the week before.
