A company linked to an outbreak of infant botulism shut down one of its plants this year after federal inspectors found numerous safety violations, according to a report New York Times.
ByHeart Inc. is implicated in the outbreak because a sample of her powdered infant formula taken from the home of a California patient tested positive for the same strain of botulism that affects children.
The company recalled all of its formulas due to an outbreak that sickened 15 babies. All 15 children received ByHeart formula. In recent weeks, the company was notified of an increase in cases of infant botulism in 84 patients since August.
Dr. Erica Pan, California's chief public health officer, said the department noticed an uptick in reports starting Aug. 1. Of the approximately 84 infants treated for botulism, about 36 were bottle-fed, including 15 who received ByHeart formula, she said.
Pan told Time that the number of infected infants consuming ByHeart formula was striking because the company's sales account for only about 1 percent of the national formula market.
“So this was a very disproportionate and very alarming signal of what's going on here,” Dr Peng told reporters. Time.
The Centers for Disease Control and Prevention reports that there are typically 130 to 180 cases of infant botulism reported each year.
In 2023 The FDA sent a warning letter at ByHeart after discovering “serious” food safety violations at one of its manufacturing facilities.
The FDA is currently investigating the ByHeart facilities in Allerton, Iowa, and Portland, Oregon, which produced the recalled formula, according to the FDA. Time story. Inspectors are trying to determine whether there is a link between the processing centers and the patients at the start of the outbreak.
“The FDA's investigation into infant botulism in the United States is still ongoing, and we believe there are too many unanswered questions,” the company said in a statement.
In December 2023, FDA inspectors found 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 agency report. Time.
At a Pennsylvania facility, the roof was leaking and inspectors noticed flies overhead in the compounding area. In the same area, the inspector noticed more than 2,500 dead bedbugs.
FDA inspectors also noted that the plant violated its own rules for maintaining temperatures necessary to eliminate bacteria from the mixture before it was sent for packaging, the report said. Temperature changes should have prompted a report to supervisor, but no notification was forthcoming and the formula was sent to clients.
Ron Belldegrun, chief executive of ByHeart, founded the company with his sister Mia Fant after a career in venture capital and hedge fund management. Fant, the company's president, helped create ByHeart after serving as a marketing and business development executive.
ByHeart has grown rapidly, raising more than $70 million from investors this spring in a deal that valued the company at more than $900 million, according to Time.
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