Congresswoman Rose DeLauro (D-CT) is concerned about the Abbott Nutrition facility reopening after Cronobacter contamination was found in the plant. In a press release, she states, “Following credible reports that Abbott Nutrition had falsified records, cut corners, and instituted substandard safety practices, the Sturgis, Michigan, facility reopened to begin manufacturing infant formula once again. Given that there is no transparency on the reopening process to the public, irresponsible is the only word that comes to mind.”
In testimony to Congress in late May 2022, FDA Commissioner Robert Califf said that inspectors had found “shocking” conditions in the plant and that it had “egregiously unsanitary” conditions. Califf added that an investigation could not conclude that those conditions led to four infant illnesses and two deaths, but he said that he could not rule it out, stating that those events happening at the same time were “highly unusual.”
Califf said that Cronobacter in the facility, leaks in the roof, cracks in equipment, and standing water in the plant contributed to the conditions. The Cronobacter strains in the plant did not match the isolates from two of the infants so an outbreak could not declared.
Abbott entered a consent decree with the FDA three weeks ago to reopen the plant. That decree required the company to take specific measures designed to increase safety and to make sure the facility was in compliance with the FDA’s Food, Drug, and Cosmetic Act and Good Manufacturing Practice requirements.
DeLauro said, “Since the beginning, I have called for the need to quickly get safe infant formula back on shelves and hold Abbott accountable for the lax practices that led to our current infant formula shortage. However, it is unclear whether the Abbott facility in Sturgis is clean enough to reopen and operate at any capacity. Moreover, it is uncertain the steps they are taking to prioritize manufacturing a safe product. When the FDA inspected the facility in January, they found cronobacter sakazakii everywhere – and that is not hyperbole. This specific bacteria can live and thrive in dry foods, such as powdered infant formula and can cause deadly sepsis or meningitis in infants. I expect there to be transparency from the FDA as to why the facility is now clean enough to reopen and begin the manufacturing of infant formula once again and how the FDA came to the decision.”
DeLauro added, “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.”
In April 2022, DeLauro submitted a whistleblower complaint that stated Abbott released untested formula, hid information from the FDA during a 2019 audit, did not take corrective action when the company knew their testing procedures were deficient, and had lax procedures with clean in place practices.
DeLauro has requsted investigations into the FDA’s handing of the powdered infant formula recall. The Health and Human Services Office of Inspector General announced that they would investigate. DeLauro has also introduced legislation to make sure that an infant formula shortage will not happen again.
