(COLUMBUS, OH) – The Abbott Nutrition plant in Sturgis could resume production of baby formulas very soon.
In a media release, Abbott says the Food And Drug Administration has completed their investigation at the Sturgis plant. On February 20, Abbott Nutrition voluntarily recalled three powder formulas that were manufactured at their Sturgis facility: Similac, Alimentum and EleCare. The recall was done after four consumer complaints related to Cronobacter sakazakii and Salmonella Newport in infants.
Two infants became sick; two tragically passed away. Abbott says during the investigation in Sturgis, Cronobacter was found in non-product contact areas, and has not been linked to any known infant illness. More specifically, genetic sequencing on the two available samples from ill infants did not match strains of Cronobacter in the Sturgis plant. The samples from the ill infants did not match each other, meaning there was no connection between the two cases.
Abbott says the FDA concluded its inspection with a 483 page letter to the company on March 18. It's a list of observations that point out where Abbott did not follow their processes and where they can improve their systems and protocols.
Company officials say they take this very seriously and responded to the letter on April 8. Abbott says they started working to address these issues, implement improvements and take corrective action even before responding to the letter.
The release says Abbott understands this situation is urgent, and getting the Sturgis plant up and running will alleviate the shortage of baby formulas available to the public. Subject to FDA approval, Abbott could restart the Sturgis plant in the next two weeks. They would begin production of EleCare, Alimentum and metabolic formulas first and then begin production of Similac and other formulas. From the time of the restart, it will take six to eight weeks before product is available on store shelves.
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