On October 19, 2021, roughly four months before Abbott Nutrition recalled batches of infant formula contaminated with the rare-but-deadly bacteria Cronobacter sakazakii, a former employee from the Michigan plant that manufactured the formula warned the FDA of food safety violations.
His warnings were ignored.
Politico reviewed a 34-page document that the former employee sent to senior food safety officials in the FDA, including then-acting Commissioner Janet Woodcock, Susan Mayne, director of the Center for Food Safety and Applied Nutrition, Judy McMeekin, associate commissioner for Regulatory Affairs, and Catherine Hermsen, assistant commissioner of the agency’s Office of Criminal Investigations.
In the document, the whistleblower outlined his safety concerns, which included lax sanitation practices as well as an allegation that plant officials purposefully falsified records about the plant’s procedures for checking for bacteria in their product.
While the whistleblower flags several safety concerns, one in particular is particularly damning. He noted that the plant had “ongoing problems” making sure that the powdered formula cans were completely sealed, saying that bits of powder would wedge into the seam of the can, “thereby jeopardizing the integrity of the seal and product safety.”
Instead of fixing this issue, the whistleblower alleges that employees would test empty cans for bacteria instead of sealed ones with powdered baby formula.
“[The] questionable practice was never disclosed or referenced in records that came to his attention. He has reason to believe that the questionable practice has not ceased and, as well, has not been disclosed to FDA officials,” reads the document.
The former employee also attested that he was fired after continuously flagging these safety concerns. His termination is currently being investigated by the Occupational Safety and Health Administration (OSHA).
“As long as one was not inclined to ‘rock the boat,’ lax practices, including regulatory violations, were consistently overlooked,” the document says.
Even before the whistleblower reached out to the FDA, there had already been reports of infants sickened with the rare bacteria. In September 2021, a month before the whistleblower reached out to the FDA, the agency received a report of an infant sick due to the deadly bacteria.
Coincidentally, the FDA conducted an inspection of the infant formula plant in question the same week they received this news and reportedly found no evidence of bacterial contamination in the formula produced at the plant.
By the time the FDA started investigating continuing cases of the rare bacterial contamination of the product, two infant deaths occurred.
The recall, combined with the ongoing backups of endless supply chains, has led to a baby formula shortage across the globe.
To see if formula you have purchased is affected by the recall, go to www.similacrecall.com or call 1-800-986-8540.