Whistleblower alerted FDA to alleged safety lapses at infant formula plant months before recalls, complaint says


The complaint was released Thursday by Representative Rosa DeLauro, D-Connecticut, chair of the House Appropriations Committee. The MP said she received the complaint this week and called her allegations “extremely disturbing”.

Abbott recalled three popular brands of powdered infant formula in February after reporting that four infants drinking infant formula made at the facility fell ill with rare and serious infections caused by the bacteria Cronobacter sakazakii. Two of the babies died. Production at the factory has been halted and remains on hiatus.

In an April 15 statement posted on the company’s website, Abbott said it was working closely with the FDA to restart plant operations.

The former employee, who worked at the Abbott Laboratories site in Sturgis, said he had seen falsified records “repeatedly” and that in most situations the information was not disclosed while they should have been.

For example, according to the complaint, the employee reported observing underreported or inaccurately described events “to limit or avoid monitoring” and the “failure to keep accurate maintenance records.”

After several samples from a batch of infant formula were found to contain microorganisms, or “microorganisms”, the whistleblower claims the factory performed a timecode deletion, in which the formula produced at around the same time the contaminated samples were discarded, but formula produced outside of these time codes was released for sale without further testing to ensure it was safe for consumption.

In 2020, according to the complaint, the product was not recalled from the market even after management became aware of a packaging integrity issue, an issue which the whistleblower said should have get the manufacturer to pull the product off the shelves and conduct more testing.

“Abbott takes employee concerns very seriously and we foster a culture of compliance to produce the best, highest quality formula,” the company said in a statement Thursday. “We empower our employees to identify and report any issues that may compromise the safety or quality of our products, which comes before any other consideration.

“Regarding the document released by Congresswoman Rosa DeLauro (D-Conn.), this former employee was terminated for serious violations of Abbott’s food safety policies. Following the termination, the former employee , through his attorney, has advanced new and growing allegations to multiple authorities. Abbott is reviewing this new document and will thoroughly investigate any new allegations.”

The complaint says the employee was fired for raising safety concerns.

“Others have also raised concerns, some with management but more often between colleagues at the Sturgis site. Given the overriding fear of retaliation, few have been as forthright as the complainant,” according to the complaint. “Ultimately, despite an admirable employment record at Abbott and elsewhere, the grievor was terminated due to his repeated compliance concerns.”

The document says the man’s dismissal is being investigated by the Occupational Safety and Health Administration.

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The complaint also says managers may have “sanitized” the records before they reached FDA inspectors. “Active efforts were undertaken and even celebrated during and after the 2019 FDA audit to prevent auditors from learning of certain events suspected of being associated with the discovery of micros in infant formula at the Sturgis site. “, says the document. He goes on to say that the Sturgis site has continued to allow lax cleaning practices.

“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 a statement read from the transcript of a committee hearing. credits. “We need to know exactly who in the company knew about this failure and the alleged attempts to hide this information from the FDA.

“I’m also concerned that the FDA reacted far too slowly to this report,” DeLauro said, noting that the agency received the whistleblower’s statement in October but only interviewed the man. in December and had not conducted an in-person inspection of the Sturgis facility until January.

DeLauro asked the inspector general of the US Department of Health and Human Services to review the FDA’s response.

The FDA responded to CNN’s questions about the pace of its response with a statement:

“We are aware that there have been questions about the timeline related to Abbott Nutrition’s infant formula recall. However, this remains an open investigation with many moving parts. Our top priority is to ensure that any recalled product manufactured at the Sturgis, Michigan plant was We are continuing to research and will continue to update our consumer alert as additional consumer safety information becomes available.

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“Once the immediate risk to the public has been addressed, we will conduct a review and, as outlined in our recently released Foodborne Outbreak Response Enhancement Plan, we will incorporate performance measures into the entire FDA food program to better assess the timeliness and effectiveness of outbreak and regulatory investigation activities,” the statement read.

Cronobacter infections in infants are almost always caused by consuming contaminated powdered formula. Cronobacter can be introduced during manufacturing but also after opening formula containers at home.

Formula types included in the recall include Similac Sensitive, Similac Pro-total Comfort, Similac Advance and Similac PM 60/40, Alimentum and EleCare.

Abbott Nutrition is also the exclusive provider for many state WIC programs. WIC, or Special Supplemental Nutrition Programs for Women, Infants, and Children, provides food for low-income mothers and their young children.

Inspection reports obtained by CNN through a US Freedom of Information Act request revealed numerous deficiencies in the facility. FDA tests found Cronobacter sakazakii bacteria on plant equipment.

In a preliminary assessment, the FDA determined that Abbott failed to take steps to prevent product contamination during manufacturing.

In a statement posted on its website in March, Abbott said it was reviewing the FDA’s submissions. “We take this seriously and are working closely with the FDA to implement corrective actions.”

“It is important to note that no Cronobacter sakazakii or Salmonella were found in any of our consumer product testing. Cronobacter sakazakii microbes from reported cases,” the statement read.

Abbott added in Thursday’s statement, “A thorough review of all available data indicates that infant formula produced at our Sturgis facility is unlikely to be the source of infection in the reported cases and is not there was no epidemic caused by the establishment’s products”.


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