The U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC) and state and local partners are investigating consumer complaints and/or reports of infant illness related to products from Abbott Nutrition’s Sturgis, MI, facility. The four ill patients are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, MI, facility.
The FDA investigators at the Abbott Nutrition facility in Sturgis, MI, collected numerous product and environmental samples:
- Five environmental subsamples collected from the Sturgis, MI, facility were positive for Cronobacter sakazakii; four were detected by the FDA and one was detected through firm-initiated testing. The positive Cronobacter sakazakii environmental samples at the Sturgis, MI, facility have been analyzed using Whole Genome Sequencing (WGS), revealing five different strains of Cronobacter sakazakii.
- Product samples collected by FDA at the facility were analyzed for Cronobacter by FDA and were found negative.
There are no additional FDA samples pending analysis at this time. On March 18, 2022, the FDA inspection at the Abbott Nutrition facility in Sturgis, MI, was completed and a Form 483 was issued that included four observations. The inspectional observations in this Form 483 do not constitute final FDA determinations of whether any condition was or is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. FDA will take appropriate action in the future – if warranted – as we continue to evaluate the 2022 inspectional findings.
At this time, CDC has completed laboratory testing for two clinical samples received related to this investigation. Analysis performed by WGS did not find these samples from patients to be a genetic match to the multiple strains of Cronobacter found in the environmental samples obtained from Abbott Nutrition’s Sturgis, MI, facility or to any other clinical isolates in the National Center for Biotechnology Informatics (NCBI) database.
The FDA is working with Abbott Nutrition to better assess the impacts of the recall and understand production capacity at other Abbott facilities that produce some of the impacted brands. We are also working with Abbott Nutrition on safe resumption of production at the Sturgis, MI, facility. We will continue discussion with Abbott Nutrition and other infant formula manufacturers and consider all tools available to support the supply of infant formula products. We are also partnering with the United State Department of Agriculture’s Food and Nutrition Service (FNS) to monitor the impact of the recall on The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Program.
