Three infant food manufacturers received warning letters from the FDA after inspections were conducted at their facilities. The letters were for violations of the Federal Food, Drug and Cosmetic Act and FDA infant formula regulations. The letters were issued to ByHeart Inc., Mead Johnson Nutrition (Beckett), and Perrigo Wisconsin LLC.
The letters “reflect findings from FDA inspections of these facilities over the last several months.” At each inspection, the FDA issued inspectional observations and exercised oversight of each firm as they initiated recalls, in December 2022, February 2023, and March 2023. The recalls were for infant formulas potentially contaminated with Cronobacter sakazakii, a pathogen that can cause serious illness and death in vulnerable infants.
The letters are being issued as part of the FDA’s normal regulatory process, and to reinforce to these firms the importance of taking appropriate corrective actions when they detect pathogens. The firms must thorough conduct root cause investigations and perform cleaning and sanitation activities. The FDA will assess the adequacy of each company’s corrective actions in their review of the responses and during the next FDA inspection.
Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition said in a statement, “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. 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. Over the last year the FDA has continued to increase our oversight of powdered infant formula facilities. These letters are a reflection of this enhanced oversight and are intended to help the industry continuously improve the safety of their manufacturing practices, so that parents and caregivers can be confident that the formula they feed their children is safe and nutritious.”
In early 2022, infant Cronobacter illnesses and two deaths were reported in Minnesota, Ohio, and Texas. Those infants had allegedly been fed powdered infant formula manufactured at the Abbott Nutrition facility in Sturgis, Michigan.
An investigation found that although Cronobacter contamination was found at that plant, the infant illnesses and deaths were not linked to Abbott’s products. FDA inspection reports about that plant stated, “You did not maintain a building used in the manufacture, processing, packing, or holding of infant formula in a clean and sanitary condition.” Abbott’s facility was shut down for months, spurring a shortage of infant formula in the country that caused panic among parents.
The FDA started importing infant formula from other countries to fill the gap left by the Abbott closure. Abbott’s formula is back on store shelves, and currently the U.S. infant supply formula has in-stock rates of 85% or higher.
