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.
– 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, according to federal records reviewed by The Associated Press.
The gap in baby formula plant inspections, brought on by the COVID-19 pandemic, is getting new scrutiny from Congress and government watchdogs investigating the series of missteps that led to the crisis. A recent bill would require the Food and Drug Administration to inspect infant formula facilities every six months. And the government’s inspector general for health has launched an inquiry into the FDA’s handling of Abbott’s facility, the largest in the U.S.
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. Baby formula manufacturers were “consistently identified as a high priority during the pandemic,” and there is currently no backlog of inspections, the agency told the AP in response to inquiries about the gaps. The agency said it skipped about 15,000 U.S. inspections due to COVID, but it has already made up about 5,000 of those, exceeding its own goals.
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. There’s no certainty that extra inspections during COVID-19 would have prevented the contamination problems at the Sturgis, Michigan, plant that was shut down. And Abbott says that its products have not been directly linked to the infections, two of which were fatal.
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