(Washington, DC) — Today, Senator Patty Murray (D-WA), Chair of the Senate Committee on Health, Education, Labor and Pensions (HELP), and Senator Bob Casey (D-PA) issued the following statements on the U.S. Food and Drug Administration’s recently released Form 483s from three inspections conducted at Abbott Nutrition’s facility.
While these Form 483s are inspectional observations and do not constitute final FDA determinations of violations, they revealed that Abbott “did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment,” and moreover “did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source.”
"This FDA report has revealed practices at an Abbott facility that are deeply troubling—and makes it all the more urgent that we get answers from Abbott, like I’ve been pushing for,” said Senator Murray. “The families of the children harmed deserve accountability from Abbott, and parents and caregivers across the country need the peace of mind that they can feed their children without fearing contaminated formula will put their loved ones in danger. I will continue staying on top of Abbott and working with regulators to ensure we get to the bottom of this contamination, and ensure action is taken to protect people from something like this happening ever again.”
“Parents and caregivers should be able to feed their children with the peace of mind that their formula is not putting them in danger,” said Senator Casey. “This is another troubling report establishing a pattern of Abbott Nutrition’s inadequate efforts to keep its products safe. Senator Murray and I have been working on getting answers from Abbott and we will keep pushing to get to the bottom of this for the families who have been put at risk by contamination, as well as those families who now fear whether they’ll be able to find enough formula for their child’s next meal.”
Last month, Senator Murray and Senator Casey pushed Abbott CEO Robert B. Ford for answers about the company’s response to dangerous bacterial contamination of several of its powder infant formula products. The company announced a recall of three infant formulas last month after contaminated products had led to multiple hospitalizations—dating back as early as September 2021—and two deaths.