Warning Letters Sent by FDA to Three Infant Formula Manufacturers for Federal Violations

The Food and Drug Administration (FDA) has taken swift action by sending warning letters to three infant formula manufacturers for violating federal safety regulations, according to an announcement made by the agency on Wednesday.

The companies, including ByHeart, Mead Johnson Nutrition, and Perrigo Wisconsin, received the letters after FDA inspections revealed violations and limited recalls of certain products due to concerns over the presence of the bacterium Cronobacter sakazakii, which can be found in dry foods.

It is important to note that the FDA’s letters do not pertain to any ongoing recalls and that currently available products from these companies are considered safe for consumers.

In its statement, the FDA clarified that these letters are part of its regular regulatory process and aim to emphasize the significance of implementing and maintaining appropriate corrective actions when pathogens are detected by manufacturers, ensuring compliance with FDA laws and regulations.

The letters require the companies to undertake comprehensive cleaning and sanitation measures, conduct investigations into the contaminations, and reassess their sanitation policies. The companies have 15 working days to develop corrective plans for FDA review. During their next inspections, the agency will also evaluate the adequacy of the companies’ responses.

Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, stated, “The FDA is committed to proactively identifying and addressing issues to prevent companies from reaching a level of concern that leads to large-scale recalls and contributes to infant formula shortages, as we experienced last year.”

He added, “Over the past year, the FDA has significantly increased oversight of powdered infant formula facilities. These letters demonstrate our enhanced oversight efforts and aim to encourage continuous improvement in manufacturing practices, ensuring that parents and caregivers can confidently provide safe and nutritious formula to their children.”

The issuance of health warnings follows a year of baby formula shortages in 2022. The FDA disclosed that the stock rates for baby formula nationwide have been at approximately 85 percent since January.

An internal investigation conducted by the FDA confirmed that the shortage resulted from a combination of health concerns, supply chain challenges, and insufficient response from the agency itself.

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