Federal inspectors knew about problems at a major baby formula plant in Michigan months before a recent recall, it was revealed on Monday.
The Food and Drug Administration (FDA) confirmed to Politico that it was aware in November that the potentially deadly Cronobacter bacteria had been detected in the Zeeland plant where Reckitt makes its Enfamil ProSobee Simply Plant-Based Infant Formula.
Inspectors “made note” of the positive test during a “limited inspection” of the Reckitt plant where the bacteria was first detected in September, the FDA said. The contaminated batch was initially destroyed.
However, two batches of Enfamil were finally recalled in February — after FDA inspectors went back for a follow-up visit, spurred by concerns from an even earlier inspection made last July, the agency told Politico.
During the February follow-up visit, inspectors “obtained additional information which, when combined with the positive sample, led to the agency’s concerns about the adequacy of cleaning in relation to the production of these two product lots that are the subject of the recall,” a spokesperson said.
Although no one was killed or injured in the contamination, it is similar to the one last year at an Abbott Nutrition plant, also in Michigan, that caused an alarming, nationwide shortage of formula.
It is also the fourth formula recall in the past year alone, more than all the formula recalls in the last decade combined, Politico said.
“It’s stunning that it’s almost identical to what happened in 2021,” Mitzi Baum, CEO of advocate group STOP Foodborne Illness, complained to the outlet of the disastrous handling of Abbott Nutrition.
It strongly suggested that the “FDA continues to be reactive” and its “internal processes … have not been fixed, Baum said.
“Lessons have not been learned,” she complained.
Other experts told the outlet that the FDA’s justification for not taking action earlier — that Reckitt was itself still investigating the cause of the contamination — was “baffling” and “inexcusable.”
“They need to do better,” said Sarah Sorscher, deputy director of regulatory affairs at the Center for Science in the Public Interest.
It was “a problem” that inspectors found the Zeeland plant failed to be “a clean and sanitary condition” in July but was allowed to continue operation with only limited follow-up inspections, scorcher said.
“If something like that is coming up, FDA should be back in there sooner to ensure that the corrective actions were adequate,” Sorscher told Politico.
However, an FDA rep insisted that the smaller recent recalls were actually a sign that it was intervening earlier to make sure the previous mass recalls were not repeated, sparking further shortages.
“As part of the FDA’s oversight to ensure safe and nutritious infant formula, the agency’s more recent engagements with manufacturers through inspections and ongoing meetings has limited the scope of these recalls and minimized disruptions to the market,” a spokesperson told Politico.
“Compared to the Abbott recall … the recent recalls are much narrower in scope, only impacting a few weeks of product with no additional facility closures,” the rep said.
Ultimately, each firm “has a responsibility to implement a constant system of sanitation and food safety controls to produce a safe product in compliance with FDA regulations,” the agency said.
Reckitt did not respond to multiple requests for comment, Politico said. The FDA’s recall notice in February said that the firm had “voluntarily” chose to yank two batches” out of an abundance of caution.”