FDA sends warning letter to 3 major formulation makers over quality control concerns

The US Food and Drug Administration has sent warning letters to three milk formula companies, indicating concerns about serious quality control issues at some manufacturing facilities.

All the warning messages on Wednesday were sent to Reckitt/Mead Johnson and Perrigo — two long-dominant industry powerhouses — and ByHeart, a relative newcomer to a previously highly concentrated market. The three companies jumped to ramp up their manufacturing amid an urgent shortage of infant formula last year in the wake of major recalls at Abbott, one of the country’s major suppliers.

ABC News was first to report last summer that several major fixture makers other than Abbott’s also had contamination concerns, particularly with Cronobacter sakazakii — and that other fixture makers had been warned by regulators about substandard conditions and critical equipment deficiencies. in time.

Along with publishing the new warning letters, the FDA also reassured Americans that it believes previous recalls of infant formula products were “effective in removing potentially contaminated batches.” The agency said parents and caregivers do not need to throw away formula or avoid purchasing it at this time.

Chronobacter bacteria can be found widely in the environment, but they can be fatal in infants. Its discovery inside Abbott’s plant in Sturgis, Michigan, last year led to a massive voluntary recall of formula in February 2022 after four infants given Abbott’s formula developed Chronobacter infections.

Two of the infants later died, although Abbott maintains there is no conclusive evidence that his formula caused infant illnesses. But Abbott’s eventual closure reverberated from coast to coast, leaving a dangerous void in the market and forcing families to grapple with empty shelves and scramble for replacements for months.

Numerous congressional hearings demanded answers from Abbott and the FDA leadership about why more efforts were not done earlier to identify the problem and fix it before it gets too bad.

But Abbott was not alone in facing these concerns about operations and pollution.

After previous tests found Chronobacter bacteria, FDA investigators say they found “significant violations” during inspections that ranged from the fall of 2022 through mid-February 2023 at the Reckitt/Mead Johnson, Perego and BayHart facilities, including without operations or conditions. The desired level that can help more. Pathogens are exacerbated.

“For more than 130 years, Perrigo has been committed to meeting the needs of consumers, parents and caregivers — and the quality and safety of our products is our top priority,” Perrigo said in a statement obtained by ABC News. “We have stringent procedures throughout our infant formula manufacturing operations and every batch of infant formula is tested to ensure it meets strict nutrition, safety and quality standards and US food requirements. and regulatory requirements for drug administration.”

The statement continued: “The letter received by Perrigo relates only to its infant formula manufacturing facility located in Wisconsin, which Perrigo acquired from Nestlé on November 1, 2022. This letter relates to a routine inspection conducted by the US Food and Drug Administration that began on March 6, 2023.” He points to the FDA’s March 8, 2023, letter to the infant formula industry outlining its 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 that ABC News first reported last year. Although the companies have taken corrective action, the agency said more is needed after recent inspections.

The letters describe multiple occasions where the FDA says a final formula tested positive for Cronobacter and instances where companies failed to adequately investigate the source of the contamination and prevent it from occurring again.

The FDA said that in some cases, companies failed to consider “other potential sources of contamination.”

In the Reckitt/Mead Johnson letter, the investigators noted that the company’s “root cause analysis did not consider other potential sources of contamination, such as the history of numerous internal cracks of varying lengths located throughout your dryer system, or multiple water leaks in your facility, or backlogs of spilled infant formula products at your facility,” stressing that the company’s investigation “did not take into account all possible sources of contamination.”

The FDA’s findings at the Reckitt facility came amid months in which the company also found Cronobacter bacteria in “high and critical hygiene areas” in its facility’s environment — from July 2022 to February 2023.

Reckitt also found Cronobacter in its final product at multiple facilities in the fall of 2022.

In February 2023, as ABC reported at the time, Reckitt issued a voluntary recall of two of its batches.

In a statement to ABC News, Reckitt/Mead Johnson Nutrition said, “Children’s safety is of the utmost importance to us and we can confirm that all of our infant formula products continue to meet the FDA’s highest standards for safety and quality.” The FDA’s communications are part of its enhanced regulatory oversight and are not related to any new concerns or issues, as they reflect the results of previous inspections. The company added that it is “confident in the accuracy of the programs we have put in place to ensure the safety of every infant formula product we ship.”

In the new warning letter sent to Perrigo, the FDA explains that Cronobacter was identified in the final formulation products on multiple occasions by the company: in two products “during an ongoing production campaign that ran from October 23, 2022 to November 2.” , 2022,” another running from January 3, 2023 through January 18, 2023, in which another batch of combination product tested positive, and another running from March 26, 2023 through April 5, 2023, in which another batch of the product tested positive.

FDA investigators say they also found Cronobacter bacteria by scanning their facility’s environment in March — noting in their letter that this “was not the first time” they had found it at that facility.

“The detection of C. sakazakii in your facility across multiple independent inspections is significant because it demonstrates that your sanitation procedures were not sufficient to significantly reduce or prevent the presence of C. sakazakii in your facility,” the FDA wrote to Perrigo. “Once C. sakazakii is established in a production area, personnel or equipment can facilitate movement of the pathogen and contamination of food contact surfaces and the final product.”

In March 2023, Perrigo also issued a voluntary recall of some of its formulas due to possible Cronobacter contamination, a recall that the FDA says it believes is “effective”.

Cronobacter was also found in ByHeart’s final formulation reported in October 2022. They issued a voluntary recall in December 2022, blaming the positive sample on a “third-party packaging facility.”

In its alert letter to ByHeart, the FDA also noted that various leaks were found at the facility, one in the roof-mounted roof in June 2022, and another in sealant “around the vent” in the dryer tower in December 2022. After “high winds and rain”.

During an environmental survey conducted the same day the leak was identified, four swabs detected Cronobacter bacteria in the dryer tower.

“Although a leak occurred in December and Cronobacter spp. was subsequently discovered by environmental survey after the leak, the root cause analysis never considered or assessed whether the leak contributed to the contamination,” the FDA letter states.

“We commend the FDA for its efforts to unify the industry’s ongoing work to raise manufacturing standards and support the agency’s strengthened oversight,” a ByHeart spokesperson said in a statement to ABC News. “Providing safe, high-quality infant formula continues to be our top priority and we can assure our customers that no ByHeart product distributed has tested positive for contaminants. There is no interruption in ByHeart manufacturing and we currently have three production plants across the US operating on it.” It works to meet the demand for our formula.”

Companies now have 15 days to respond to the warning letters.