U.S. regulators have historically inspected baby formula plants at least once a year, but they did not inspect any of the three biggest manufacturers in 2020.
Only three of the nation’s 23 facilities that make, package or distribute formula made the cut. The FDA resumed routine inspections in July 2021.
“The FDA would have had more chances to catch these issues if they’d been inspecting during the pandemic,” said Sarah Sorscher, a food safety specialist with the Center for Science in the Public Interest. She acknowledged the difficult trade-off the FDA faced in pulling its inspectors to reduce their exposure to COVID-19. “Certainly there was a price to pay for protecting their workers during that time.
“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,” FDA stated. FDA Commissioner Robert Califf says regulators knew shutting down Abbott’s plant would create supply problems, but there was little evidence of urgency between when inspectors shuttered the plant in February and recent emergency measures to allow more imports from abroad.
The FDA shares oversight of food production and safety with the U.S. Department of Agriculture. FDA inspections of food facilities peaked in 2011 and have declined most years since, despite increased funds and powers by Congress. The FDA said that while U.S. inspections have declined, foreign facility inspections have increased.
“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 said. “And this facility would have been among those.”
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