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Tags: abbott | baby formula | whistleblower

FDA: Baby Formula Whistleblower Report Didn't Reach Top Staff for Months

the abbott nutrition plant in sturgis michigan is pictured
The Abbott Nutrition plant in Sturgis, Michigan (Photo by Jeff Kowalsky/AFP via Getty Images)

By    |   Wednesday, 25 May 2022 12:10 PM EDT

Senior officials with the Food and Drug Administration for months did not receive a whistleblower’s report alleging safety violations at an Abbott Nutrition plant in Sturgis, Michigan, due to an issue with the mailroom, the agency’s top official will acknowledge Wednesday when he faces lawmakers on Capitol Hill, reports Politico.

The February shutdown of the Michigan plant, the largest in the U.S., contributed to a nationwide shortage of baby formula. It took the FDA at least two months to interview the whistleblower and another month to inspect the plant.

An FDA inspection in January found five different strains of a potentially deadly bacteria known as Cronobacter sakazakii, the bacteria that sickened four infants.

FDA Commissioner Robert Califf and other senior officials plan to testify that the whistleblower report did not reach higher-ups at the agency until mid-February, blaming “mailroom issues” and COVID-19 staffing issues.

Rep. Rosa DeLauro, D-Conn., told Politico the FDA dropped the ball, “at every step of this process. It put infants at risk.”

Califf’s testimony will also address why the FDA waited until January to inspect the plant, according to the report.

But when they did, the FDA’s inspection team “observed significant operational deficiencies,” according to the testimony.

“The totality of evidence obtained during our inspection caused FDA to conclude that infant formulas produced at this plant were produced under insanitary conditions and may be contaminated with Cronobacter,” the testimony says.

The administration will also argue that the FDA “since the first day … has worked tirelessly with U.S. government partners to mitigate the supply chain disruption for both regular and specialty formulas.”

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Newsfront
Senior officials with the Food and Drug Administration for months did not receive a whistleblower’s report alleging safety violations at an Abbott Nutrition plant in Sturgis, Michigan, the agency’s top official will acknowledge Wednesday when he faces lawmakers on Capitol Hill, reports Politico.
abbott, baby formula, whistleblower
267
2022-10-25
Wednesday, 25 May 2022 12:10 PM
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