The FDA has sent warning letters to three formula manufacturers expressing concerns about serious quality control problems at some manufacturing facilities.
The warning letters were all sent Wednesday to Reckitt/Mead Johnson and Perrigo — two long-dominant industry forces — and ByHeart, a relative newcomer in a previously hyper-concentrated market. All three companies stepped in last year to ramp up production amid an urgent shortage of baby formula following major recalls at Abbott, one of the country’s largest suppliers.
ABC News was first to report last summer that, in addition to Abbott, several major formula makers were struggling with contamination problems, particularly with the bacteria Cronobacter sakazakii – and that these other formula makers had been warned by regulators about poor conditions and critical equipment deficiencies the time.
In addition to issuing new warning letters, the FDA also reassured Americans that it believes previous recalls of baby food products “have effectively removed the potentially contaminated batches.” The agency said parents and caregivers do not need to avoid or forego purchasing infant formula at this time.
Cronobacter is common in the environment – but it can be fatal in infants. Its discovery at the Abbott plant in Sturgis, Michigan, last year triggered a massive voluntary recall of infant formula in February 2022 after four babies who consumed Abbott’s infant formula contracted Cronobacter infections.
Two of the infants subsequently died, although Abbott cites no conclusive evidence that his formula caused the babies’ illnesses. But Abbott’s permanent closure struck from coast to coast, leaving a huge hole in the market and forcing families to struggle with empty shelves for months and search for alternatives.
Normally fully stocked shelves of Baby Forumala are empty at a Target store in Queens, New York, on June 23, 2022. Universal Images Group via Getty Images, FILE
Numerous congressional hearings demanded answers from Abbott and FDA leadership about why more wasn’t done to identify and fix the problem before it got so bad.
But Abbott wasn’t the only one facing these operational and contamination issues.
After earlier testing detected Cronobacter, FDA investigators said they found “significant violations,” including substandard processes or conditions, during inspections from fall 2022 to mid-February 2023 at Reckitt/Mead Johnson, Perrigo and ByHeart facilities could help more pathogens fester.
“Perrigo has been committed to meeting the needs of consumers, parents and caregivers for over 130 years – and the quality and safety of our products is our top priority,” Perrigo said in a statement obtained by ABC News. “We use rigorous processes to produce our infant formula and each batch of infant formula is tested to ensure it meets the strict nutritional, safety, quality and regulatory requirements of the U.S. Food & Drug Administration.”
“The letter Perrigo received only addressed its infant formula manufacturing facility in Wisconsin, which Perrigo acquired from Nestlé on November 1, 2022,” the statement continued. “This letter relates to a routine FDA inspection that began on March 6, 2023,” and references FDA’s March 8, 2023 notice to the infant formula industry outlining evolving regulatory expectations. We are carefully reviewing the FDA’s letter and plan to work closely with the agency.”
The new warning letters detail some of the same concerns ABC News first reported last year. And while companies have taken corrective action, the agency said more is needed after these recent inspections.
The letters describe several cases in which the FDA says the finished formula tested positive for Cronobacter and cases in which the companies failed to adequately investigate the source of the contamination and prevent recurrence.
In some cases, the companies failed to consider “other potential sources of contamination,” the FDA said.
In the Reckitt/Mead Johnson letter, investigators note that the company’s “root cause analysis” did not consider other potential sources of contamination, “such as having piles of spilled infant formula at your facility,” and emphasizes that the company’s investigation “not all.” potential sources of contamination have been taken into account”.
The FDA’s findings at Reckitt’s facility occurred during a period in which the company also found Cronobacter in “high and critical hygiene zones” around its facility – from July 2022 to February 2023.
Reckitt also found Cronobacter in its finished formula at several facilities in the fall of 2022.
As ABC reported at the time, Reckitt issued a voluntary recall for two of its batches in February 2023.
In a statement to ABC News, Reckitt/Mead Johnson Nutrition said, “The safety of babies is of the utmost importance to us and we can confirm that all of our infant formula products continue to meet the highest FDA standards for safety and quality,” the FDA statement said is part of their enhanced regulatory oversight and does not address new concerns or issues as it reflects findings from previous inspections. The company added that it is “confident in the rigor of the programs we have in place to ensure the safety of all infant formula products we ship.”
In the new warning letter to Perrigo, the FDA details that Cronobacter was identified by the company in finished formula products on multiple occasions: in two products “during a continuous production campaign that ran from October 23, 2022 to November 2.” , 2022,” another that ran from January 3, 2023 to January 18, 2023 and in which a different batch formula product tested positive, and another that ran from March 26, 2023 to April 5, 2023 and in which another batch of…product tested positive.
FDA investigators said they also found Cronobacter in swabs around their facility in March of this year – and noted in their letter that this was “not the first time” they had found Cronobacter at that facility.
“The detection of C. sakazakii in your facility during multiple independent inspections is significant in that it shows that your sanitation measures were not sufficient to significantly minimize or prevent the presence of C. sakazakii in your facility,” writes the FDA to Perrigo. “Once C. sakazakii becomes established in a production area, personnel or equipment can facilitate the spread of the pathogen and contamination of food contact surfaces and finished products.”
In March 2023, Perrigo also issued a voluntary recall of some of its formulas due to possible Cronobacter contamination, a recall that the FDA said was “effective.”
Cronobacter was also found in ByHeart’s finished formula, which the company reported in October 2022. In December 2022, they issued a voluntary recall, blaming the “third-party packaging facility” for the positive sample.
In its warning letter to ByHeart, the FDA also notes that several leaks were discovered at the facility, one in the skylight installed on the roof in June 2022 and one in December 2022 in a worn sealant “around the louvers” in a dryer tower after “severe Wind and rain.”
During an environmental sampling conducted the same day the leak was discovered, four samples detected Cronobacter in the dryer tower.
“Although there was a leak in December and then Cronobacter spp. “Detected through swabs of the post-leak environment, the root cause analysis never considered or assessed whether the leak may have contributed to the contamination,” the FDA letter said.
“We commend the FDA for its efforts to unify the industry’s ongoing work to raise manufacturing standards and support the agency’s increased oversight,” a ByHeart spokesperson said in a statement to ABC News. “Providing safe, high-quality infant formula remains our top priority and we can assure our customers that no ByHeart product sold has tested positive for contaminants. There is no disruption to ByHeart’s production and we currently have three manufacturing facilities in the U.S. working to meet demand for our formula.”
The companies now have 15 days to respond to the warnings.