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Federal inspectors spotted the potential for baby formula made at an Abbott Laboratories plant to become contaminated months before a recall that exacerbated a nationwide shortage, a government document shows.
The Food and Drug Administration report adds a new twist to the widening gap between supply and demand for formula since Abbott recalled Similac and other top-selling brands in February, alarming parents — including those in Iowa — and stoking lawmakers' concerns.
Federal officials have investigated the cases of four babies who fell ill — including two who died — from cronobacter after ingesting formula made at Abbott's Sturgis, Mich., plant.
U.S. officials are putting increasing focus on the crisis. The White House has tried to reassure parents that supplies will be replenished, and President Joe Biden met Thursday with manufacturers and retailers to find ways to increase supply.
Abbott said this week that it could restart production in coming weeks and get formula back on shelves within two months, pending clearance from the FDA.
The FDA report obtained by Bloomberg News through a freedom of information request shows that during a routine visit to Abbott's Sturgis manufacturing facility in September, inspectors determined that employees may have transferred contaminants including deadly cronobacter from surfaces to baby formula. In one instance, the report said, records showed Abbott detected cronobacter in a finished batch of formula that may have been tainted by a worker who touched a contaminated surface without changing gloves. That batch wasn't distributed.
Abbott has said its formula isn't to blame for sickening the infants. "There is no evidence to link our formulas to these infant illnesses," the company said in a statement to Bloomberg, without commenting on the detailed inspection report. Abbott has previously said that it found cronobacter in formula that it didn't distribute in 2019 and 2020, and the FDA has said its inspectors again discovered the pathogen in the plant this year.
The company has drawn a distinction between contaminants found on equipment involved in production and microbes detected in the wider environment at the plant. Abbott has said that testing hasn't found cronobacter on anything that comes into direct contact with formula substance. But the 39-page FDA document reviewed by Bloomberg shows that inspectors observed how the products could still become contaminated.
In the detailed report on their September visit, two FDA inspectors said they observed an Abbott processing operator touching "non-food contact surfaces" — essentially anywhere in the facility that doesn't come in contact with formula. Without changing his gloves or sanitizing his hands, the same worker touched the inside of a bag of ingredients that was being weighed.
Such practices can present "a food safety hazard," the inspectors wrote in September. As an example of how it might lead to contamination, inspectors highlighted an instance in June 2020 when a batch of Similac For Spit-Up formula — which wasn't distributed — tested positive for cronobacter.
Abbott had listed poor manufacturing practices as a probable cause of that contamination event, including a worker touching a hoist and then opening something, "without sanitized, gloved hand." Specifics of what the worker opened are redacted in the report.
The document also detailed five instances of positive tests for cronobacter in environmental, non-food samples from the plant from January 2019 to August 2021.
Minnesota health officials first told the FDA in September about an infant who had ingested Abbott formula and fallen sick with cronobacter. After three additional reports of sick babies over the next few months, the FDA sent inspectors back to the Michigan plant in January. During that inspection, Abbott recalled three formula brands made there: Similac, Alimentum and EleCare. Based on agency inspectors' findings over several weeks earlier this year, production at the plant was halted — worsening shortages that had arisen earlier from supply chain issues.
Abbott said it has been working to address the food safety violations the FDA found in the inspection earlier this year and to upgrade the plant, "including installing non-porous, easily cleanable and sanitary floors."
Government officials' tests of unopened formula containers at the homes of the four sick babies were all negative for cronobacter, Abbott said, and one of three open containers from the homes tested positive. The positive one contained two different strains of cronobacter: one that matched the strain that caused the infant's infection and another matching germs found on a bottle of distilled water used to mix the formula, Abbott said.
Government officials also did genetic testing and found the cronobacter strains found at the Abbott plant don't match the ones taken from two infants' samples. The lack of matching strains from sickened infants' samples add to the evidence from testing of its machinery that the plant wasn't likely to be involved in the outbreak, the company said.
The inspection earlier this year turned up five different cronobacter strains at the Michigan plant. That could indicate sporadic contamination that may be brought about by poor manufacturing practices, said Craig Hedberg, co-director of the Minnesota Integrated Food Safety Center of Excellence.
"If this is the case," said Francisco Diez-Gonzalez, director of the Center for Food Safety at the University of Georgia, "it may explain why the strains they found when they went to the plant may not be the same that were there when the product was contaminated."
Utah Republican Sen. Mitt Romney wrote FDA Commissioner Robert Califf on Tuesday out of concern for the shortages and the agency's handling of the recall. Based on a summary of the September inspection, which the FDA made public in March, Romney said he was alarmed and asked if more was known that wasn't included in the overview. The summary doesn't refer to cronobacter and has much less information than the report reviewed by Bloomberg.
The summary "suggests FDA's routine inspection authority is insufficient to meet consumer safety demands, yet its hammer of near-shutdowns of facilities causes a ripple effect throughout the country," Romney wrote.