Infant formula manufacturer linked to botulism outbreak had known problems

ByHeart, the company linked to an infant botulism outbreak, closed one of its manufacturing plants this year after federal investigators found a series of safety violations, including a leaky roof and hundreds of dead insects, where it made infant formula.

Food and Drug Administration inspection reports detailed significant problems at the company’s Reading, Pennsylvania, facility. Although the reports did not affect the plants that made the formula recalled in the botulism outbreak, food experts say the findings raise concerns about the company’s safety record.

For example, in July and August 2022, ByHeart found Cronobacter sakazakii, a bacteria that can be fatal to infants, in the processing area of ​​the facility. When the company also found the bacteria in a can of ready-to-eat food weeks later, it criticized the laboratory that had discovered it.

Months later, FDA inspectors returned to the Pennsylvania manufacturing site, discovered mold in a tank that was supposed to contain clean water, found more than 2,700 dead insects in a food production area and learned that the plant was struggling with multiple roof leaks. The FDA classified the inspection as highly concerning.

Now the FDA is investigating the company’s facilities in Allerton, Iowa, and Portland, Oregon, which manufactured the formula that has been widely recalled from supermarket shelves. Inspectors are trying to determine whether there is a connection between the processing centers and the 15 infants who were treated for botulism toxicity after consuming ByHeart formula, officials said. No deaths were reported.

“We express our deepest condolences to the families currently affected by the cases of infant botulism,” said Mia Funt, the company’s president. “We are working with the FDA and independent experts to quickly implement the recall while the factual investigation continues.”

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