FDA issued warning letters to three infant formula manufacturers on Wednesday as part of a commitment to ensure that the industry is producing infant formula under the safest conditions possible.
These letters warned of violations of the Federal Food, Drug, and Cosmetic Act and the FDA’s Infant Formula regulations. They were issued to ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC. They reflect findings from FDA inspections of these facilities over the last several months. At the time of each inspection, the FDA issued observations and exercised oversight of each firm as they initiated recalls in December 2022, February 2023, and March 2023 to remove product potentially contaminated with cronobacter sakazakii.
The FDA does not advise parents and caregivers to discard or avoid purchasing any infant formula at this time. The agency is not aware of any distributed product where contamination was confirmed and believes that the recalls were effective in removing the potentially contaminated batches of product from the market.
“Infant formula manufacturers are responsible for ensuring they make safe products, and the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns,” said Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, in a statement. “The FDA is committed to identifying and acting on issues early to prevent any firms from reaching the level of concern that prompted last year’s large-scale recall and contributed to the infant formula shortage.”
These warning letters are not associated with any current recalls, so the current supply of infant formula on the market should not be affected, according to the FDA.
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