Abbott restarts production of its biggest and most popular formula after months of hiatus


Abbott announced on Friday that its Sturgis, Michigan plant is restarting production of its largest and most popular infant formula, Similac.

Previously, the troubled plant had restarted only part of its production, after problems with bacterial contamination inside the facility prompted a months-long voluntary recall and shutdown.

The shutdown of the country’s largest infant formula maker has ricocheted off the infant formula industry and exacerbated the supply shortage, forcing families to rush to find alternatives in the hyper-concentrated infant formula market.

Then in June – less than two weeks after finally restarting some of its formula production – bad weather and flooding forced the plant to close again to “assess the damage”, “clean and disinfect the plant again “.

In July, Abbott announced it was opening lines of its specialty hypoallergenic formula, EleCare, as well as some metabolic formulas — but still not its most popular and widely used Similac.

The company is now announcing that it has restarted production of Similac, paving the way for a possible infusion of formula milk into the US market, once the plant is back to full capacity – after what has been a shortage of several months on the shelves of American grocery stores.

FILE PHOTO: A cabinet of baby formula is seen at a Walmart store in Raleigh, North Carolina, U.S., June 2, 2022. Picture taken June 2, 2022. REUTERS/Arriana Mclymore/File Photo

Staff/Reuters

The discovery of Cronobacter sakazakii bacteria inside Abbott’s Sturgis plant prompted a massive voluntary formula recall in February, after four babies who consumed Abbott’s formula contracted a Cronobacter infection. Two of the infants later died, although Abbott maintains there was no conclusive evidence that his formula caused the childhood illnesses, as none of the strains of Cronobacter found in their factory matched the two samples. genetically sequenced sick infants. Ultimately, it was the combined findings of Cronobacter inside Abbott’s plant — along with a series of serious operational shortcomings and consumer complaints — that led to its closure.

Now that they are reopening production of Similac, Abbott estimates it will take them about six weeks to begin shipping it to retail outlets “as it enters production, enhanced pre- and post-production testing and cycles through the shipping and retail distribution networks,” a spokesperson said.

Abbott tells ABC News that while they were shutting down and reviewing the systems, there were “a few” instances where they again found Cronobacter in batches of their formula. In each case, they claim to have found it, fixed the problem, and destroyed the affected product.

It’s basically the surveillance system at work: Cronobacter can be widely present in the environment — but in infants it can be deadly — so rigorous safety and Quality at factories like these is so important, experts previously told ABC News.

US President Joe Biden, flanked by Sameera Fazili, Deputy Assistant to the President and Deputy Director of the National Economic Council, holds a meeting with White House officials and infant formula manufacturers.

FILE PHOTO: US President Joe Biden, flanked by Sameera Fazili, Deputy Assistant to the President and Deputy Director of the National Economic Council, holds a meeting with White House officials and infant formula manufacturers, as part of the U.S. response to the current infant formula shortage, in an auditorium on the White House campus in Washington, U.S., June 1, 2022. REUTERS/Jonathan Ernst/File Photo

Jonathan Ernst/Reuters

“Restarting a large manufacturing plant after a months-long shutdown is a complex process, and it takes time to ensure equipment, processes and production are running smoothly and sustainably,” a doorman said. -say Abbott in a statement to be released this evening on their place. “It’s taken us time to ramp up production steadily to these high standards. There have been – and likely will be – shutdowns and restarts from time to time. We’ve experienced things like bad weather, we had to make mechanical adjustments, and we had to throw away some early production batches that didn’t meet our standards.”

“As we said, we have a zero tolerance policy for Cronobacter or any pathogen in our plants. Cronobacter is found naturally and commonly in the environment and our quality systems are designed to find and destroy it when it is there because it is sometimes the case with all manufacturers, which is why we test it regularly and take steps to eliminate it if and when we find it, which is why we have taken the measures that we took in Sturgis in February, and that’s what guides our approach today,” the spokesperson said.

“If our quality systems detect the presence of Cronobacter in product testing, we suspend production while we investigate and coordinate closely with the FDA. Since our restart, this has happened with a few batches, and in those cases, we have found the problem, solved it and no affected product has been or will be distributed.This confirms the work of our quality system.

ABC News

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