Other formula makers besides Abbott have faced Cronobacter challenges, ABC News has found.
Normally fully stocked shelves of baby forumala are empty in a Target store in Queens, New York, June 23, 2022.
Nearly a decade's worth of FDA inspections obtained through the regulatory intelligence company Redica Systems and reviewed by ABC News have found the presence of Cronobacter in environmental sampling, in critical and high-hygiene areas, and even in finished product from some of these formula manufacturers' American plants.
The right set of circumstances can compound a perfect storm of risk factors for potentially dangerous pathogens to survive, experts say -- and that's especially worrisome when a contaminant like Cronobacter lurks where food is made for babies, who are among those most vulnerable to that germ. The employee was subsequently retrained, Mead Johnson told the FDA, according to inspection documents. But it was not the first time investigators had flagged concerns at one of Mead Johnson's plants.
"Cronobacter is an environmental pathogen -- it's everywhere," food safety attorney Bill Marler said. "But it's really, really bad to have it in infant formula." FDA investigators followed up with the Zeeland plant in spring 2018. The facility had retooled its sanitization procedures, implemented dryer inspections, and made repairs to flooring, water infiltration, and caulking.Returning in March 2019, investigators noted the plant's environmental monitoring program had identified and mitigated several instances of Cronobacter in various areas of the plant.
First Lady Jill Biden, joined by Surgeon General Vivek Murthy, delivers remarks after a shipment of infant formula, sent in through Operation Fly Formula, arrived at Dulles International Airport in Dulles, Va., May 25, 2022.
Lynn, who reviewed the inspection documents obtained by ABC News, noted that there appear to be "problematic similarities" among some of the formula manufacturers' lapses in quality control, including "issues with inadequate process controls, including cleaning, sampling and ultimately controlling the production environment to assure there is no microbial contamination," he said.
FDA investigators discussed their findings and suggested remedies with management, but did not issue a Form 483 at that time, according to inspection documents reviewed by ABC News.A Gerber spokesperson told ABC News that their infant formulas go through up to 500 quality and safety checks, "many of which are above and beyond regulatory requirements."
In a statement to ABC News, Perrigo said they are "proud" of their compliance track record, adding that the Cronobacter within the plant had been found by their own self-monitoring, rather than by FDA investigators. "Everybody knows what the persistent problems are that cause bacterial contamination in product," said Marler, the food safety attorney. "It's cracks, water, old equipment. It's when companies stop realizing they're producing food that is going into the bodies of babies and they start thinking about it as a widget, as a commodity."
Food safety experts ABC spoke with emphasized the importance of establishing -- and adhering to -- a proactive protocol for rooting out risk factors, before they snowball. Further complicating the matter is that Cronobacter infection is listed as a reportable illness by only one U.S. state: Minnesota, where the first of the four infants was reported infected after consuming Abbott's formula last September.
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Did an Abbott Representative Offer Grieving Uvalde Family Money To Oppose Gun Control?Despite citing no sources, evidence, or links of any kind, the three tweets that pushed this rumor still received a massive number of shares. Combined, they were retweeted a total of more than 68,000 times and received more than 244,000 likes.
Read more »
Gov. Abbott spent hours at fundraiser after Uvalde shootingTexas Gov. Greg Abbott has said that he stopped at a campaign fundraiser following the deadly school shooting in Uvalde and “let people know” he couldn’t stay, but a newspaper reports that he was there for nearly three hours.
Read more »
Gov. Abbott tells D.C. mayor to 'stop attacking Texas' as migrant buses create humanitarian crisisThe mayor says she needs help from the National Guard to prevent a spiraling crisis created by Abbott and fellow Republican Gov. Doug Ducey of Arizona. Texas GregAbbott Immigration washingtondc migrants DougDucey Arizona Republicans
Read more »
FDA says multiple infant formula makers face Cronobacter contamination, operational deficienciesSome of the operational deficiencies that helped trigger the massive shutdown of Abbott Nutrition's infant formula plant earlier this year have also been found at some other companies' factories, according to an ABC News investigation of some of the other formula makers that have stepped in to help fill empty American grocery shelves in the midst of the critical nationwide shortage.
Read more »
FDA says multiple infant formula makers face Cronobacter contamination, operational deficienciesSome of the operational deficiencies that helped trigger the massive shutdown of Abbott Nutrition's infant formula plant earlier this year have also been found at some other companies' factories, according to an ABC News investigation of some of the other formula makers that have stepped in to help fill empty American grocery shelves in the midst of the critical nationwide shortage.
Read more »
FDA says multiple infant formula makers face Cronobacter contamination, operational deficienciesSome of the operational deficiencies that helped trigger the massive shutdown of Abbott Nutrition's infant formula plant earlier this year have also been found at some other companies' factories, according to an ABC News investigation of some of the other formula makers that have stepped in to help fill empty American grocery shelves in the midst of the critical nationwide shortage.
Read more »