FDA audited over baby formula crisis

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(NEW YORK) — The Health and Human Services’ Office of Inspector General is launching an audit into how the Food and Drug Administration responded leading up to the massive February recall of baby formula and closure of Abbott Nutrition’s Sturgis plant.

OIG will examine whether the FDA upheld its duty “to safeguard the nation’s food supply, including infant formula and ensure all ingredients are safe” and if FDA regulators followed proper recall protocol once a deadly bacteria had been detected inside the plant.

The Sturgis, Michigan, plant was shut down in mid-February after contamination issues inside had been linked to four infants being hospitalized with a rare but serious bacterial infection, two of whom ultimately died.

The review of the FDA’s actions marks an extraordinary and uncommon move from the watchdog agency.

The American public and lawmakers alike have been searching for accountability on the ongoing infant formula shortage — a now-national supply crisis which was exacerbated by Abbott’s contamination issues and ultimate shutdown.

This is not first time Abbott’s quality control had come under questioning.

Federal regulators warned months ago of potential problems at a manufacturing plant for baby formula, according to documents and a public timeline of the events.

The FDA found sanitation issues at Abbott’s Sturgis plant in September 2021, saying it “did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition,” according to an inspection report.

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