Inspectors found multiple problems at ByHeart infant formula production plants
The company linked to an outbreak of infant botulism closed one of its manufacturing plants this year after federal inspectors found numerous safety violations, according to a newspaper report. New York Times.
ByHeart Inc. is implicated in the outbreak because a sample of its powdered infant formula taken from a California patient’s home tested positive for the same strain of botulism that sickens babies.
The company recalled all of its formula due to the outbreak, which sickened 15 confirmed babies. All 15 babies were fed ByHeart formula. The company has been informed in recent weeks of an increase in cases of infant botulism affecting 84 patients since August.
California Public Health Officer Dr. Erica Pan said the department noticed an increase in reports starting Aug. 1. Of about 84 infants treated for botulism, she said, about 36 were fed formula, including 15 who ingested ByHeart formula.
Pan said to Times that the number of infected infants who consumed ByHeart formula stood out to him, because the company’s sales represent only about 1 percent of the national formula market.
“So it was a very disproportionate and very worrying signal of what’s happening here,” Dr. Pan told the Times.
The Centers for Disease Control and Prevention reports that approximately 130 to 180 cases of infant botulism are reported each year.
In 2023, the FDA sent a warning letter to ByHeart after finding “serious” food safety violations at one of its production facilities.
The FDA is currently investigating the ByHeart facilities in Allerton, IA, and Portland, Oregon, that produced the recalled formula, according to the Times history. Inspectors are trying to determine if there is a link between treatment centers and patients with the outbreak.
“The FDA’s investigation into infant botulism in the United States is still ongoing and we believe there are still too many unanswered questions,” the company said in a statement.
In December 2023, FDA inspectors discovered problems at ByHeart’s manufacturing facility in Pennsylvania, according to an agency inspection report provided by Redica Systems, a company that collects and sells the reports, according to the Times.
The Pennsylvania plant had a leaking roof and inspectors observed flies above an infant formula production area. In the same area, the inspector observed more than 2,500 dead bedbugs.
FDA inspectors also noted that the factory violated its own rules for maintaining temperatures necessary to remove bacteria from the formula before it was shipped for packaging, the report said. The temperature variations should have resulted in a report to a supervisor, but no notification occurred and the formula was distributed to customers.
Ron Belldegrun, chief executive of ByHeart, founded the company with Mia Funt, his sister, after a career in venture capital and hedge fund management. Funt, the company’s president, helped found ByHeart after working as a marketing and business development manager.
ByHeart has grown rapidly, raising more than $70 million this spring from investors in a deal valuing the company at more than $900 million, according to the Times.
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