The US Department of Justice opened a criminal investigation last week into an Abbott Laboratories plant in Michigan over unsanitary workplace conditions in its production of baby formula – the latest probe into one of the country’s biggest baby formula makers after the closure of the plant last year fuelled a nationwide shortage.
Towards the end of 2021, a whistle-blower who had previously worked at the facility sent a 34-page document to the US Food and Drug Administration (FDA) alleging sloppy cleaning protocols and falsified records intended to keep the FDA in the dark about issues at the plant, which was eventually made public in 2022.
Forbes reports that in February last year, Abbott announced a recall of its products made at its Michigan plant, including its primary baby formula line Similac, and two others, after complaints from consumers over two cases of bacterial infections in infants who had been fed the powdered formula (the company said it found no evidence of the bacteria in its routine testing).
The FDA, as well as Canadian officials, immediately warned consumers not to use baby formula from the facility, with Canadian officials warning that formula containing the bacteria Cronobacter sakazakii “may not look or smell spoiled but can still make you sick”.
A fortnight later, the FDA reported that two infants had died in hospital after contracting a bacterial illness from Cronobacter sakazakii after consuming the formula, saying the illness “may have contributed to their death”.
The following month, an FDA inspection found standing water in the facility as well as cases of staff, who worked directly with the formula, not thoroughly washing their hands.
The plant was closed, while the company continued to deny its formula contained the bacteria, saying its focus “has, is and always will be to ensure safe food for families”.
However, major retailers limited customer purchases of baby formula as the nationwide shortage intensified, made worse by supply-chain issues, while Abbott said it was “doing everything” in its power to fix the shortage.
In August that year, Abbott announced it would restart production of Similac at its Michigan plant, with CEO Robert Ford acknowledging the shortage had been “difficult for the families we serve” and calling the reopening an “important milestone”.
An Abbott Laboratories spokesperson told Forbes this week that the company is “co-operating fully” with the investigation, but would not provide further details.
Abbott holds a 43% share of baby formula market sales, according to a 2011 USDA report.
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