Whistleblower alerted FDA to alleged safety lapses at baby formula plant months before recalls, complaint shows

By CNN Newsource

Published April 28, 2022 6:49 PM

By Brenda Goodman and Jacqueline Howard, CNN

A former employee of Abbott Nutrition documented his concerns that the company was hiding safety problems at its Sturgis, Mich., production facility and sent a detailed complaint to the US Food and Drug Administration months before infant formula was removed from grocery store shelves.

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

Abbott recalled three popular brands of powdered infant formula in February after reports that four infants drinking formula manufactured at the facility had fallen ill with rare and serious infections caused by Cronobacter sakazakii bacteria. Two of the babies died. Production at the facility was halted and remains paused.

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

The former employee, who worked at Abbott Laboratories’ Sturgis site, stated that he saw records falsified “on multiple occasions,” and in most situations, information was not disclosed when it should have been.

For instance, according to the complaint, the employee reported observing events that were understated or inaccurately described “to limit or avoid oversight” and the “failing to maintain accurate maintenance records.”

After several samples of a batch of infant formula were found to contain microorganisms, or “micros,” the whistleblower claims that the plant performed a time code removal, in which formula produced around the same time as the contaminated samples was discarded, but formula produced outside of those time codes was released to be sold without additional testing to make sure it was safe for consumption.

In 2020, the complaint says, product wasn’t recalled from the market even after management became aware of a problem with the integrity of the packaging, an issue that the whistleblower said should have caused the manufacturer to take the product off shelves and conduct more testing.

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

“With regard to the document released by Congresswoman Rosa DeLauro (D-Conn.) this former employee 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 complaint says the employee was fired for raising safety concerns.

“Others also raised concerns, some with management but more often among colleagues at the Sturgis site. Given the overriding fear of retaliation, few were as outspoken as the Complainant,” according to the complaint. “Ultimately despite an admirable employment record at Abbott and elsewhere, Complainant was terminated based upon his repeated elevation of compliance concerns.”

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

The complaint also says that managers may have been “sanitizing” files before they reached FDA inspectors. “Active efforts were undertaken and even celebrated during and after the 2019 FDA audit to keep the auditors from learning of certain events believed to be associated with the discovery of micros in infant formula at the Sturgis site,” the document says. It goes on to claim that the Sturgis site has continued to permit lax practices around cleaning.

“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 into the record of an Appropriations Committee hearing. “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,” DeLauro said, noting that the agency had received the whistleblower’s statement in October but did not interview the man until December and did not do an in-person inspection of the Sturgis facility until January.

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

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

“We know 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. We are continuing to investigate and will continue to update our consumer alert should additional consumer safety information become available.

“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 Improvement Plan, we will build in performance measures across the FDA’s foods program to better evaluate the timeliness and effectiveness of outbreak and regulatory investigation activities,” the statement says.

Cronobacter infections in infants are almost always caused by drinking contaminated powdered baby formula. Cronobacter can be introduced during manufacturing but also after containers of formula are opened 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 supplier for many state WIC programs. WIC, or Special Supplemental Nutrition Programs for Women, Infants, and Children, supplies food to low-income mothers and their young children.

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

In a preliminary assessment, the FDA determined that Abbott did not take steps to prevent products from becoming contaminated during manufacturing.

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

“It is important to note that no Cronobacter sakazakii or Salmonella was found in any of our testing of products distributed to consumers. Additionally, the unique genetic makeup of the Cronobacter sakazakii microbes found in non-product contact areas at the Sturgis facility did not match the Cronobacter sakazakii microbes from the reported cases,” the statement says.

Abbott added in Thursday’s statement, “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.”