Hard copies of the disclosure were sent via FedEx to senior food safety officials and other leaders at FDA. They included FDA’s top official, 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 addition to the serious questions raised about Abbott Nutrition’s food safety practices, revelations of an early whistleblower warning reinforce concerns about leadership and decision making on food issues at the agency, something POLITICO reported on in an investigation earlier this month, as well as the rigor of FDA’s plant inspections.

The whistleblower document was publicly revealed Thursday morning by House Appropriations Chair Rosa DeLauro during a budget hearing on Capitol Hill. The Connecticut Democrat — a longtime proponent for food safety and maternal health policies — expressed frustration that the agency had apparently not heeded the warning.

“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. “I am equally concerned that the FDA reacted far too slowly to this report.”

The congresswoman said that the agency did not interview the whistleblower until December. FDA didn’t inspect the plant until Jan. 31. Formula was recalled Feb. 17.

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

Asked to comment, the FDA did not acknowledge the whistleblower disclosure nor offer an explanation about why the allegations did not spark more immediate action.

“We know there have been questions about the timeline related to the Abbott Nutrition infant formula recall,” an agency spokesperson said. “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. We are continuing to investigate and will continue to update our consumer alert should additional consumer safety information become available.”

A spokesperson for Abbott Nutrition alleged that the former employee raising concerns had been “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,” the spokesperson said. “Abbott is reviewing this new document and will thoroughly investigate any new allegations.”

The company maintains it is not the source of the infections.

“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 spokesperson said.

Serious questions have already been raised about the government’s handling of the investigation into the Abbott formula plant and the Cronobacter sakazakii cases. As POLITICO first reported, FDA was told of the first infant Cronobacter case in Minnesota on Sept. 20. The next day, the agency said it contacted Abbott Nutrition because the infant had reportedly consumed formula made by the company.

Coincidentally, that very same week in September, FDA conducted a routine inspection of the plant and found it had some sanitation problems, but nothing so serious as to warrant regulatory action. It’s not clear whether inspectors were told about the hospitalized infant. The agency has declined to answer specific questions about that inspection, which happened after a two year break. FDA usually inspects formula plants at least once a year, but routine food safety inspections were temporarily suspended during the pandemic.

In October, the former plant employee, whose name is redacted in the disclosure, flagged concerns directly to seven FDA officials. In addition to the high level officials, the document was also sent to the directors of regional FDA offices in Chicago and Detroit and Andrea Lotze, a nutrition official at CFSAN, in both hard copy and email form.

In the document, the former employee said he was fired after repeatedly raising food safety compliance concerns. (The termination is being investigated by OSHA, under a whistleblower complaint provision in the Food Safety Modernization Act, according to the document.)

The former employee described a plant where current and former employees are “fearful of retaliation” — a dynamic made more extreme by the fact that Abbott is the highest paying and largest employer in Sturgis.

“It is a workplace where fear of retaliation is palpable,” according to the document. “The basis for that fear is well founded.”

While working at the plant, the former employee said he increasingly became concerned the plant — which typically produces a significant share of the country’s infant formula supply — was not complying with FDA’s strict requirements for infant formula production.

“As long as one was not inclined to ‘rock the boat,’ lax practices, including regulatory violations, were consistently overlooked,” the document says.

The document alleges that plant officials “knowingly” falsified records on a number of occasions — most often it was a practice of leaving off key information from compliance records. The plant continued to rely in part on paper records, which made it more difficult for them to be reviewed.

Other allegations raise questions about the overall food safety culture of the plant. The document notes that the Sturgis plant had “ongoing problems” with ensuring that its powdered formula cans were fully sealed. Essentially, powder would get into the can seams “thereby jeopardizing the integrity of the seal and product safety,” according to the document.

Instead of addressing the problem head on, there were instances in which employees altered the plant’s testing process so that empty cans were tested instead of sealed cans containing the product, according to the document. The former employee indicated that this “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,” the document says.

In 2019, a batch of the plant’s infant formula tested positive for “micros,” according to the document. It doesn’t specify which bacteria was found, but formula is routinely tested for Salmonella and Cronobacter. Plant officials decided that instead of destroying the entire batch, they would destroy the most suspect part of the batch and then release the rest of it into the market without conducting additional testing to ensure it wasn’t contaminated.

“The infant formula was released commercially without supporting documentation to suggest it was compliant and safe for consumption,” the document says.

During FDA’s routine 2019 inspection of the Sturgis plant, company officials were “worried what the FDA would find about the micro batches,” the document says.

“Throughout the audit, [quality assurance] leadership kept [quality systems] staff apprised,” it continues. “One member of management stated that the FDA was on the ‘right trail.’ She even volunteered that she was amazed that the FDA was unable to discover what occurred with the micro batches. Once the FDA audit was over, staff and department managers congratulated each other on a successful FDA audit.”

It’s not clear what actions FDA officials took, if any, following the October warning. The agency has not yet responded to the report.

In the weeks that followed, more babies fell ill with serious Cronobacter infections. FDA received three more complaints between November and January, including two cases where the infants died. A Salmonella case was initially included in the investigation but has since been dropped due to insufficient evidence linking it to the plant.

FDA officials interviewed the whistleblower sometime in December, DeLauro said Thursday.

FDA initiated a weeks-long inspection in response to the Cronobacter complaints on Jan. 31. Inspectors ultimately uncovered serious food safety issues and found five strains of Cronobacter in the plant, though none of the strains matched the two samples of bacteria that underwent genetic sequencing in cases where infants were hospitalized, a fact that has undoubtedly complicated the investigation.

Abbott Nutrition and FDA ultimately announced a massive recall of infant formula Feb. 17 — roughly five months after the first known hospitalization.

The agency, which has repeatedly declined to explain the investigational timeline, has maintained it is focused on the recall and mitigating the current public health risk, and will review its investigation and response after “the immediate risk to the public has been addressed.”

Woodcock, FDA’s principal deputy commissioner — who was sent a copy of the whistleblower’s disclosure in October when she was serving as acting commissioner — told POLITICO in an interview last month that the review will be done out of her office and “it will be very intensive.”

In addition to the questions it raises about the oversight of this particular formula plant, the revelation of the early whistleblower warning points to a breakdown in FDA’s internal communication — a consequence of a broken leadership structure and an open power struggle within the foods division at the agency, something that POLITICO recently reported on.

Both the CFSAN director Susan Mayne, and Judy McMeekin, the head of the Office of Regulatory Affairs, the division that oversees all of FDA’s inspectional activities, were sent a copy of the whistleblower disclosure, but it apparently was not sent to Frank Yiannas, deputy commissioner for food policy and response. Yiannas was not informed about the whistleblower warning the agency had received in October until February, according to a source familiar — raising significant questions about the agency’s internal communication regarding the incident.

Rep. DeLauro, for her part, has asked the Health and Human Services Office of the Inspector General to conduct an independent investigation. Sens. Patty Murray (D-Wash.) and Bob Casey (D-Pa.) have demanded that Abbott Nutrition hand over information and documents related to the company’s infant formula recall.

DeLauro on Thursday also urged USDA to look into the incident because Abbott Nutrition’s Similac brand formula — the top brand in the U.S. — is one of the major suppliers to USDA’s Special Supplemental Nutrition Program for Women, Infants, and Children, known as WIC, which provides formula for millions of low-income parents and caregivers.

“I strongly encourage you to investigate USDA’s contracts with Abbott Nutrition,” DeLauro said, at Thursday’s committee hearing with Agriculture Secretary Tom Vilsack. “If Abbott cannot guarantee the safety of formula purchased through the WIC program, the federal government should not be in business with them.”