RECIPE FOR DISASTER

FDA Bungled Whistleblower Warnings on Baby Formula Plant, Report Says

The FDA was alerted to unsanitary conditions at the factory months before an inspection eventually took place.

A 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, according to The Washington Post. By the time the report was received and acted upon in late January, two infants were hospitalized and a third died after allegedly consuming formula made at the factory in Sturgis, Michigan. A former quality assurance worker at the plant had attempted to raise the alarm by putting together a report alleging a litany of failings at the plant—ranging from falsifying records to using sloppy cleaning practices—and sent it to several FDA officials. But Frank Yiannas, the FDA’s deputy commissioner for food policy and response, was not informed about the explosive dossier for months. A widespread national shortage of baby formula was triggered when the plant was shut down and a product recall was issued following a damning inspection in early 2022.