U.S. FDA Issues Warnings to Three Infant Formula Makers for Manufacturing Process Issues
August 30, 2021
The U.S. Food and Drug Administration (FDA) has issued warnings to three infant formula makers to address concerns regarding their manufacturing processes and enhance their ability to detect bacterial contamination. The FDA stated that while corrective actions are necessary, it does not anticipate any impact on the availability of infant formula.
The three companies that received warning letters from the regulatory body are ByHeart Inc, Mead Johnson Nutrition (a unit of Reckitt Benckiser Group), and Perrigo’s Wisconsin unit. The FDA called out these companies for their failure to establish robust processes to prevent contamination during the manufacturing of infant formula.
Perrigo, one of the companies in question, responded to the FDA’s letter by stating that they are carefully reviewing it and intend to collaborate closely with the agency. The spokesperson assured that all of their infant formula products comply with the FDA’s food safety requirements and are safe for parents and caregivers.
It is important to note that the FDA’s warning letters are not associated with any ongoing product recalls. They are instead related to observations made by the agency following recalls made by the three companies between December and March. These recalls were initiated to remove potentially contaminated products infected with the bacteria cronobacter sakazakii.
The FDA expressed its belief that the recalls were effective in removing the possibly contaminated batches of infant formula from the market.
Infant formula manufacturing processes have come under increased scrutiny recently, particularly due to the shortage of the product last year caused by the shutdown of Abbott Laboratories’ unit in Michigan. Abbott’s facility faced complaints of bacterial infections related to their formulas, which led to recalls and the closure of the facility.
At the time of reporting, Reckitt and ByHeart had not responded to requests for comments regarding the FDA’s warnings.
This news comes from Leroy Leo in Bengaluru and has been edited by Krishna Chandra Eluri.
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