FDA Warns Three Baby Formula Manufacturers Over Manufacturing Process Controls

The FDA has issued warning letters to three infant formula manufacturers, ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC, for violations of regulations and the Federal Food, Drug, and Cosmetic Act. The warning letters come after FDA inspections and recalls initiated by the companies to remove potentially contaminated products from the market. The FDA emphasizes that there is no need for parents and caregivers to discard or avoid purchasing any particular infant formula at this time. The agency is focused on enhancing regulatory oversight and ensuring the safety of infant formula manufacturing practices. The FDA will assess the companies' corrective actions and continue to strengthen the safety and resiliency of the infant formula supply in the U.S.