The FDA commissioner is set to answer questions from House lawmakers investigating what led up to the U.S. 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. Several FDA staffers reviewed the complaint in late October, but officials didn’t request an interview until early December. Because of conflicts with the whistleblower’s schedule, the interview didn’t take place until Dec. 22, according to the FDA testimony.
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