Former Abbott Employee Alerted FDA to Concerns About Baby Formula Months Before Recall

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A former employee at Abbott Nutrition sent a detailed complaint to the US Food and Drug Administration months before they took their baby formula off the shelves. Prior to the recall, four babies got sick after drinking baby formula produced by Abbott Nutrition. Tragically, two of the babies died.

Had the FDA acted immediately, these tragedies might have been prevented. Babies are our most vulnerable members of society and they deserve our most stringent protections. If it is even conceivable that a baby could become sick, and the FDA is notified, it must act URGENTLY.

Representative Rosa DeLauro received the 34 page complaint and said it was “extremely disturbing.” Rep. DeLauro went further:

“In September 2021, FDA learned of the potential link between a rare and deadly foodborne pathogen and powdered infant formula manufactured by Abbott Laboratories in a facility in Sturgis, Michigan. This week I received a 34-page report from a whistleblower, a former employee at the plant which produced the contaminated formula – which led to at least 4 hospitalizations and the deaths of at least 2 babies. The whistleblower report lays out a damning list of allegations of wrongdoing at this factory, including:

  • 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.”
Courtesy of the House Appropriations Committee via Relevant part begins at 57:37

While Abbott Nutrition has a lot to say about their former employee, that does not negate the FDA’s failure to act immediately. The “Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”

Why should parents, or any of us, feel any confidence in federal agencies if this sort of thing is allowed to happen? Please sound off.

Stacey Warner

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