Efforts to inspect an Abbott baby formula factory linked to the nationwide shortage were delayed by various reasons, according to the FDA.
The first batch of imported baby formula under "Operation Fly Formula" arrived in the United States on Sunday as the Biden administration tries to alleviate the nationwide baby formula shortage.
Califf will tell lawmakers that the FDA began planning to visit the Sturgis, Michigan, plant in early December, with inspectors set to arrive on Dec. 30. But Abbott said that about a dozen of its employees had recently tested positive for COVID-19 and requested a delay. As a result, the FDA didn't begin its inspection until Jan. 31.
"Because it was a negotiation process with a regulated firm, the U.S. government did not completely control the timeline," states Califf's written testimony.
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