According to federal records reviewed by the Associated Press, at least once a year the US regulators have historically inspected infant formula plants. However, in 2020, none of the three largest manufacturers were inspected.
After a two-year gap, US regulators eventually got inside an Abbott Nutrition formula plant in Michigan, where they discovered stagnant water and sloppy cleaning standards. Inspectors, on the other hand, issued no formal warnings, and only gave voluntary solutions to the problems.
Following several reports about infants who had been given the formula had bacterial infections, inspectors returned to the same plant five months later and inside the factory, they found bacterial contamination, leading to a four-month shutdown and a nationwide formula crisis.
The report also noted that the Food and Drug Administration only investigated three of the nation’s 23 formula manufacturing, packaging, and distribution facilities in 2020. The FDA resumed routine inspections in 2021, but some factories had been closed for as long as two and a half years by the time inspectors arrived.
The FDA informed the Associated Press that baby formula producers were “consistently designated as a high priority during the epidemic,” and that there is now no inspection backlog.
The department said, “Our top priority now is addressing the urgent need for infant formula in the U.S. market, and our teams are working night and day to help make that happen.”
Now, the gap in baby formula plant inspections, brought on by the Covid-19 pandemic, is getting new scrutiny from Congress. Abbott shut down its Michigan factory in February, where bacterial infections sickened four babies but the company denies the allegation and said, “There was no direct link between its products and the infections.”
The facility had a history of contamination difficulties, Steven Mandernach said, an executive director of the Association of Food and Drug Officials.
“I think facilities that had known problems that could cause a food safety risk should have been part of FDA’s mission-critical work,” Mandernach told the AP. “And this facility would have been among those.”
In early June, Abbott finally resumed production at its Michigan facility but it’s still not sufficient to meet the current demand. Lawmakers are concerned about possible errors leading up to the disruption of the formula supply chain.
Congress would mandate a six-month examination. In addition, the FDA’s handling of Abbott is being investigated by the government.
Sources: Westernjournal, Chicagotribune, Apnews
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