A new whistleblower report alleges that Abbott Nutrition was lax on concerns about contaminated infant formula, according to information released by Representative Rosa DeLauro (D-CT). DeLauro is the House Appropriations Committee Chair. She submitted the report for the record on April 28, 2022.
The whistleblower allegedly worked at the Abbott facility that produces infant formula that was recalled for possible Cronobacter contamination in February 2022. In September 2021 the FDA learned of a potential link between Cronobacter and Similac powdered infant formula. The 34-page report from the whistleblower has allegations of wrongdoing at the facility. They include:
Falsification of records relating to testing of seals, signing verifications without adequate knowledge, failure to maintain accurate maintenance records, shipping packages with fill weights lower than what was on the label, and more;
Releasing untested infant formula;
Hiding information during a 2019 FDA audit;
Lax practices associated with clean in place procedures;
Lack of traceability of the product;
Failure to take corrective measures once the company knew their testing procedures were deficient;
An atmosphere of retaliation against any employee who raised concerns about company practices.
DeLauro states, “And these are just a few of the allegations laid out in the report. I want to remind everyone we are talking about infant formula. Parents trust that formula will be safe and healthy for their newborn babies – it should be the most regulated of any product.
I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. We need to know exactly who in the company was aware of this failure and the alleged attempts to hide this information from the FDA.
I am equally concerned that the FDA reacted far too slowly to this report. The report was submitted to the FDA on October 20, 2021. The FDA did not interview the whistleblower until late December 2021. According to news reports, FDA did not inspect the plant in person until January 31, 2022, and the recall was not issued until February 17, 2022.
Why did the FDA not spring into action? Why did it take four months to pull this formula off store shelves? How many infants were fed contaminated formula during this time, by parents who trusted that the formula they were buying was safe? How many additional illnesses and deaths were there due to FDA’s slow response?”
Abbott recalled potentially contaminated infant formula in February 2022. Since this news broke, the FDA has stated that the environmental swabs in the Abbott facility that were positive for Cronobacter did not match the isolates taken from ill infants. And the isolates from the infants did not match each other.
Abbott contacted Food Poisoning Bulletin on May 1st and provided a link to its statement in response to the whistleblower allegations.
