May 17, 2022 – Abbott has agreed to enter a consent decree with the 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.
Once the FDA confirms the initial requirements for start-up have been met, Abbott could restart the site within two weeks. Abbott would begin production of EleCare®, Alimentum® and metabolic formulas first and then begin production of Similac® and other formulas. From the time Abbott restarts the site, it will take six to eight weeks before the product is available on shelves.
Abbott has been working on corrective actions since the FDA inspection and submitted a response and corrective action plan to FDA on April 8. Even before its formal response, Abbott had begun working to implement improvements and take corrective action. Some of these actions included reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating protocols regarding water, cleaning and maintenance procedures at the facility. Abbott immediately implemented corrections to address the items that the FDA raised in its observations provided at the conclusion of the inspection. The company has also been making upgrades to the plant.
After a thorough investigation by the FDA, the CDC and Abbott, and review of all available data, there is no conclusive evidence to link Abbott’s formulas to these infant illnesses. Specifically:
- 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.