In prepared remarks, the FDA head gives the first detailed account of why it took his agency months to inspect the plant after first learning of potential problems last fall.
FDA Commissioner Robert Califf laid out a series of setbacks in congressional testimony that slowed his agency’s response, including a COVID-19 outbreak at the plant and a whistleblower complaint that didn’t reach FDA leadership because it was apparently lost in the mail.
“Why did it take an onslaught of national media attention for the Biden administration to act with a sense of urgency required to address an infant formula shortage?” asked Rep. Morgan Griffith, R-Virginia, the committee’s ranking Republican. After detecting positive samples of a rare-but-dangerous bacteria in multiple parts of the plant, the FDA closed the facility and Abbott announced a massive recall of its formula on Feb. 17.
Several FDA staffers reviewed the complaint in late October when it was sent to a regional FDA office, but an interview didn’t take place until two months later, in part due to the whistleblower’s scheduling conflicts.
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FDA Chief to Detail Why Inspection of Baby Formula Plant Was DelayedThe head of the Food and Drug Administration is preparing to tell lawmakers about events that led to a months-long gap before inspecting the plant at the center of a nationwide baby formula shortage.
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FDA chief to detail delays inspecting baby formula plantThe head of the Food and Drug Administration is preparing to tell lawmakers about events that led to a months-long gap before inspecting the plant at the center of a nationwide baby formula shortage.
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FDA Chief to Detail Delays Inspecting Baby Formula PlantThe head of the Food and Drug Administration is preparing to tell lawmakers about events that led to a months-long gap before inspecting the plant at the center of a nationwide baby formula shortage. FDA Commissioner Robert Califf is scheduled to answer questions Wednesday from House lawmakers probing the formula shortage. According to prepared testimony, Califf will tell lawmakers that a COVID-19 outbreak at Abbott’s formula plant led regulators to delay their inspection from late December to January. Califf will also discuss delays in interviewing an Abbott whistleblower who alleged serious violations at the baby formula plant last October.
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FDA chief to detail delays inspecting baby formula plantThe head of the Food and Drug Administration is preparing to tell lawmakers about events that led to a months-long gap before inspecting the plant at the center of a nationwide baby formula shortage.
Weiterlesen »
FDA Bungled Whistleblower Warnings on Baby Formula Plant, Report SaysA whistleblower report sent to the Food and Drug Administration in October 2020 alleging lapses in safety at an Abbott infant formula plant didn’t reach the FDA’s top food safety official for four months
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FDA chief to detail delays inspecting baby formula plantFederal plans to inspect a baby formula factory linked to the nationwide shortage were slowed by COVID-19, scheduling conflicts and other logistical problems, according to prepared testimony from the head of the Food and Drug Administration.
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