Abbott Nutrition has resumed operations at its baby formula plant which was shut down by the FDA in mid-February because of dirty conditions and a link to a cronobacter outbreak that saw two babies die.
Even though the plant has resumed operations, company officials say it could take up to six weeks before the product is available.
The plant in Sturgis, MI, had to meet “hundreds” of requirements before reopening according to Food and Drug Administration Commissioner Robert Califf who testified before a congressional panel in late mid-May.
The closing of the plant — and a subsequent recall of a massive amount of infant formula — sparked a shortage of infant formula that caused an interruption in supplies of more than 70 percent, according to Datasembly, which tracks retail data. The shortage found parents driving from store to store in search of food for their babes. The FDA loosened requirements so companies could import infant formula from foreign countries.
Abbott has almost 50 percent of the market share of the infant formula market in the United States.
The FDA began investigating the Sturgis plant four months after an initial complaint from Minnesota, which had confirmed a cronobacter infection in a baby that had been fed Abbott’s product. An opened can of formula from the home tested positive but was not an exact match for any of the five strains of the bacteria in the plant.
Ultimately four infants were diagnosed with cronobacter infections and two of them died.
Officials with Abbott Nutrition, including Christopher J. Calamari, a senior vice president who testified before Congress, said the plant was not responsible because none of the five cronobacter strains found in the plant was a perfect match for the Minnesota case and samples were not available from all four babies.
During that hearing commissioner, Califf told members of the U.S. House of Representatives that the agency found “disgusting” conditions at the production plant and that he did not have confidence that it could be reopened without federal intervention.
Consequently, the FDA filed a complaint with the Department of Justice that resulted in a consent decree between the federal government and Abbott Nutrition. Abbott agreed to meet requirements before reopening and remain under strict scrutiny by the FDA.
The re-start of the facility brought some comments from Congresswoman Rosa DeLauro (CT-03), Chair of the House Appropriations Committee. She said:
“Given the recent Department of Justice consent decree and recent testimony by the FDA that this facility was ‘several weeks’ away from a safe reopening,, how, within a span of just 10 days, did they remediate all of these problems?
“What inspection was done of the Sturgis, Michigan, facility prior to reopening, and what were the reported findings? I will not stand for the potential of a contaminated product being rereleased onto the market to threaten the lives of babies once more. I expect answers as to what precautions have been taken at the FDA and by Abbott Nutrition to ensure that the plant is sterile and stands no risk to the health of our children.”
DeLauro has been closely tracking this issue since Abbott Nutrition first announced the formula recall which has driven the nationwide shortage. She examined the recall at a hearing and submitted for the record a report acquired from a whistleblower who worked at the Abbott facility which produces infant formula recalled by the Food and Drug Administration (FDA) in February. She has also requested investigationsinto the FDA’s handling of the Abbott powdered formula recall, which the Health and Human Services Office of Inspector General recently announced they would investigate.
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