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safefoodmitra.com · 2023-09-01 23:43:38
According to the FDA, the warning letters were for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and issued to ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC. In a press release published Wednesday, the agency said the letters reflect findings from FDA inspections of the companies’ facilities over the last several months. At the time of each inspection, they initiated recalls to remove products potentially contaminated with Cronobacter sakazakii – a germ or pathogenic bacteria that can cause illness, primarily among infants – from the marketplace. The FDA said it does not advise parents and caregivers to discard or avoid purchasing any particular infant formula at this time, as the agency is not aware of any distributed product where contamination was confirmed and believes that the recalls were effective in removing the potentially contaminated batches of product from the market. Additionally, these warning letters are not associated with any current recalls and therefore the FDA does not anticipate any impact on the availability of infant formula on the market. The FDA said it is issuing these letters now as part of its normal regulatory process and to reinforce to these firms the importance of instituting and maintaining appropriate corrective actions when they detect pathogens to ensure compliance with the FDA’s laws and regulations. Each company will have 15 working days to respond to the FDA to explain what corrective actions they are taking such as conducting root cause investigations and performing subsequent cleaning and sanitation activities.

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