FDA issues warning letters to 3 infant formula manufacturers

The U.S. Food and Drug Administration (FDA) has issued warning letters to three infant formula manufacturers as part of its commitment to ensuring the safest possible production of infant formula. 

These warning letters were issued to ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC, citing violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA’s actions are based on findings from recent inspections of these companies’ facilities.

During these inspections, recalls were initiated by the companies to remove potentially contaminated products from the market. The contamination risk involved Cronobacter sakazakii, a pathogenic bacteria that can cause illness, primarily in infants.

The FDA has emphasized that it is not advising parents and caregivers to dispose of or avoid purchasing any specific infant formula at this time. 

The agency is unaware of any confirmed contamination in distributed products and believes that the recalls were effective in removing potentially contaminated batches from the market. Furthermore, these warning letters are not linked to any current recalls, so there is no expected impact on the availability of infant formula in the market.

The issuance of these warning letters is a standard part of the FDA’s regulatory process and serves to emphasize to these companies the importance of implementing and maintaining appropriate corrective actions when pathogens are detected, ensuring compliance with FDA laws and regulations.

Each of the companies will have 15 working days to respond to the FDA and explain the corrective actions they are taking, including root cause investigations and subsequent cleaning and sanitation efforts. The FDA will assess the adequacy of these corrective actions through its review of the companies’ responses and during its next inspections of their facilities, verifying the proper implementation of appropriate measures.