formula supply - a market that had already begun to show signs of strain from pandemic supply chain disruptions.

The drastic move quickly slashed a significant share of the U.S. Abbott maintains there is no conclusive evidence that its products contributed to the death of two infants.īut it wasn't until mid-February when Abbott, the largest infant formula manufacturer in the country, issued a voluntary recall. 1, FDA had collected samples at the plant confirming the presence of cronobacter, according to an inspection report. 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.īy Feb. This is not first time Abbott's quality control has come under questioning.įederal regulators warned months ago of potential problems at a manufacturing plant for baby formula, according to documents and a public timeline of the events. Its advent also punctuates loud, frustrated calls from the American public and lawmakers alike for accountability on the ongoing infant formula shortage - a now-national supply crisis which was exacerbated by Abbott's contamination issues and ultimate shutdown.

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

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