Abbott resumes production of infant formula under strict eye of FDA

Abbott Nutrition has resumer operations at its baby formula plant that 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 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 the state of 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 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, senior vice president who testified before Congress, said the plant was not responsible because none of five cronobacter strains found in the plant were 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.