A whistleblower notified the FDA about concerns with a facility that made infant formula. Months later, 2 babies died after consuming it.

• The FDA in February said two babies died potentially from bacteria linked to infant formula.
• Abbott Nutrition recalled lots of some formulas made in their Sturgis, Michigan, plant.

A whistleblower notified the Food and Drug Administration about concerns with a plant that produces infant formula months before two babies died and the products were recalled, according to a newly revealed document.

The FDA said in February it was investigating reports of bacterial infections related to powdered infant formula made at Abbott Nutrition's plant in Sturgis, Michigan. Abbott Nutrition recalled select lots of its Similac, Alimentum, and EleCare formulas.

The FDA said two deaths had been reported and that a "Cronobacter infection may have contributed to the cause of death for both patients."

In mid-October, months before the deaths and recalls, a whistleblower sent the FDA a 34-page document outlining potential concerns with the Sturgis plant, Rep. Rosa DeLauro revealed in a statement on Thursday.

The document, written by a former plant employee, accused the plant of lax cleaning practices, falsifying records, releasing untested infant formula, and hiding information during an FDA audit in 2019, among other issues.

"I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility," DeLauro said in the statement, adding: "I am equally concerned that the FDA reacted far too slowly to this report."

"Why did the FDA not spring into action?" she said. "Why did it take four months to pull this formula off store shelves? How many infants were fed contaminated formula during this time?"

In a statement to Insider, the FDA acknowledged "there have been questions about the timeline related to the Abbott Nutrition infant formula recall."

"However, this remains an open investigation with many moving parts. Our top priority is ensuring that any recalled product produced at the Sturgis, Mich. facility has been removed from the market," the statement said. "We are continuing to investigate and will continue to update our consumer alert should additional consumer safety information become available."

In a statement provided to Insider, a spokesperson for Abbott Nutrition said the former employee who wrote the document "was dismissed due to serious violations of Abbott's food safety policies."

"After dismissal, the former employee, through their attorney, has made evolving, new and escalating allegations to multiple authorities. Abbott is reviewing this new document and will thoroughly investigate any new allegations," the statement said.

It also said an investigation conducted by Abbott and the FDA did not identify Cronobacter or Salmonella in any of its products that were tested.

"A thorough review of all available data indicates that the infant formula produced at our Sturgis facility is not likely the source of infection in the reported cases and that there was not an outbreak caused by products from the facility," the statement said.

The recalls have also contributed to recent shortages in infant formulas that have prompted retailers such as CVS, Walgreens, and Target to limit the amount customers are allowed to buy at one time.

One mother in Glendale, California, told Insider she has been scrambling to try and find formula for her 11-month-old son, who is sensitive to dairy and relies on Nutramigen, a hypoallergenic formula.

"It's impossible to find anywhere," Julie Berger said in a phone interview with Insider on Thursday, adding that for babies like hers with a dairy sensitivity, "there's very few formulas that really end up vibing with them."

While the formula that works for her son has not been recalled, Alimentum, another hypoallergenic formula, was part of the recall, which could be prompting more mothers to seek out Nutramigen.

For the past week or so Berger has been constantly searching stores in person and online in Los Angeles and San Diego, where her parents live, but said it's nearly impossible to find any in stock.

She said she's thankful her son is a little older, because now he can eat some solid food and does not rely on formula alone: "If he was any younger we would've been really up shit's creek."

Are you a parent struggling to find infant formula? Contact this reporter at kvlamis@insider.com.