Three infant formula makers took insufficient action after cronobacter, the dangerous pathogen that led to a disruptive recall, was found in their manufacturing facilities and products, US regulators said.
(Bloomberg) — Three infant formula makers took insufficient action after cronobacter, the dangerous pathogen that led to a disruptive recall, was found in their manufacturing facilities and products, US regulators said.
Violations were found in Michigan and Minnesota plants operated by Reckitt Benckiser Group Plc’s Mead Johnson unit, Perrigo Co.’s facility in Wisconsin, and a ByHeart Inc. facility at an undisclosed location, according to warning letters to the companies on Wednesday. In all cases, inspectors found cronobacter in critical hygiene zones of the facilities, and the companies failed to quickly notify the FDA when contaminated batches of product left the facility.
“We are in the process of carefully reviewing FDA’s letter and plan to work closely with the agency,” a Perrigo spokesperson said in an email. Reckitt is also reviewing the contents of the letter and plans to send back a comprehensive response, according to a spokesperson.
ByHeart didn’t immediately respond to requests for comment.
Last year, a nationwide shortage of infant formula occurred after cronobacter was discovered at an Abbott Laboratories facility. The FDA has faced criticism that it responded slowly to questions about the Abbott site.
The agency has increased its oversight of powdered infant formula facilities over the past year, said Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition. The FDA said caregivers shouldn’t throw away or avoid buying any formula at this time, and that the warnings weren’t expected to affect the availability of infant formula on the market.
The actions are “intended to help the industry continuously improve the safety of their manufacturing practices, so that parents and caregivers can be confident that the formula they feed their children is safe and nutritious,” he said Wednesday in a separate statement.
The infant formula issue is one of several facing incoming Deputy Commissioner for Human Foods US environmental official James Jones, who was named last week.
(Adds comment from Reckitt in third paragraph.)
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