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FDA Issues Warning Letters to Three Infant Formula Manufacturers


According to an August 30th release, the Food and Drug Administration issued warning letters to ByHeart Inc, Mead Johnson Nutrition and Perrigo Wisconsin, LLC.  The warning letters relate to inspections carried out on plants during December 2022 and during the first quarter of 2023. 


Effectively, the responses submitted by manufacturers to post-inspection FDA Forms 483 were inadequate and the warning letters outlined areas of concern relating to potential contamination with Cronobacter sakazakii. It is characteristic of the FDA that follow-up warning letters are sent to manufacturers only months after inspections and receipt of responses.  


It is intended that Cronobacter sakazakii infection will be designated as reportable through the Nationally Notifiable Conditions List as recommended by the Centers for Disease Control and Prevention with the support of the Council of State and Territorial Epidemiologists. 


The FDA emphasized that there is currently no evidence of contamination of U.S. infant formula and that supply has functioned with an in-stock rate of 85 percent or higher since the beginning of 2023.


The FDA has advised parents and caregivers not to discard any purchased infant formula manufactured by any of the three implicated companies at this time. The warning letters are intended to “re-enforce the importance of instituting and maintaining appropriate corrective actions when pathogens are detected and to ensure compliance with FDA laws and regulations”.