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.
Bubs Australia struck a deal with American grocery chains to import the formula under the fourth flight of Operation Fly Formula, the company said.When they finally did get inside an Abbott Nutrition formula plant in Michigan after a two-year gap, they found standing water and lax sanitation procedures. But inspectors offered only voluntary suggestions for fixing the problems, and issued no formal warning.
As COVID-19 swept across the U.S. in early 2020, the FDA pulled most of its safety inspectors from the field, skipping thousands of routine plant inspections. In fact, the FDA still has yet to return to one key plant owned by Reckitt and two owned by Gerber, according to agency records. All those facilities are operating around the clock to boost U.S. formula production.
“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. “It’s very challenging for them to get engaged at all in this area because they don’t have the background, the knowledge and the experience in it,” said Steven Mandernach, executive director of the Association of Food and Drug Officials, which represents state-level inspectors.
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