FDA Finds No Evidence of Bacteria at Shuttered Baby Formula Facility that Sparked Crisis

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STURGIS, MI – The FDA has allowed the Abbott company’s Sturgis baby formula manufacturing plant to reopen after shutting down the plant for three months sparking a nationwide baby formula shortage and crisis.

That’s the good news. The bad news is the company says it will be at least two months before any new product will hit the shelves and even longer for the popular Similac brand of baby food. The baby formula crisis will be with Americans for a few more months.

On Monday, Abbott agreed to enter into a consent decree with the U.S. Food and Drug Administration (FDA) related to its Sturgis, Mich., infant formula plant. The decree is an agreement between FDA and Abbott on the steps necessary to resume production and maintain the facility. This does not affect any other Abbott plant or operation. The decree is subject to court approval.

The federal government shut down the plant in February after two infants allegedly died from bacteria the CDC said originated from the plant.

After a thorough investigation by FDA, Centers for Disease Control and Prevention (CDC) and Abbott, and a review of all available data, there is no conclusive evidence to link Abbott’s formulas to these infant illnesses, the company said on Monday.

Here’s what the federal investigation revealed:

  • CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses.
  • Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakiior Salmonella.
  • All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility.
  • The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness.
  • Genetic sequencing on the two available samples from ill infants did not match the strains of Cronobacter sakazakii found in our plant. Samples from ill infants did not match each other, which means there was no connection between the two cases.
  • In all four cases, the state, FDA and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative.
  • Open containers from the homes of the infants were also tested in three of the four cases; two of the three tested negative. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of Cronobacter sakazakii, one of which matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula. Again, neither strain matched strains found in our plant.
  • The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states.

“Our safety and quality processes meet even the toughest scrutiny and we’re committed to continuously improving our processes and protocols,” said Mr. Ford. “Nutrition is fundamental to Abbott and to our goal of improving the lives of more than 3 billion people by decade’s end. We intend to set the standard for the industry, raising the bar on both safety and quality.”

During the process, Abbott has been working to meet the demands of the public, but the Sturgis shutdown sent shockwaves through the supply chain.

The company said it has air-shipped millions of cans of infant formula powder into the U.S. from our FDA-registered facility in Cootehill, Ireland. It has also prioritized infant formula production at its Columbus, Ohio, facility, converting other liquid manufacturing lines into manufacturing Similac liquid ready-to-feed and ramped production at our other U.S. manufacturing site in Casa Grande, Arizona, for powder infant formula.

Last week, White House Press Secretary Jen Psaki blamed scared moms for the supply crisis, saying moms are now hoarding baby formula for their infants negating the positive effects of the newly increase in supply.

“We’ve already seen an increase in supply over the past couple of weeks.  What we are seeing, which is an enormous problem, is hoarding.  People hoarding because they’re fearful.” Psaki said. “So that is also something we’re focused on taking efforts to track and adjust — and address and look into.”