Tainted baby-formula risk was seen months before recall
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 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 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, Michigan, 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 ingredient 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.