Complaints show whistleblowers alerted the Food and Drug Administration to alleged safety gaps in infant formula factories months before the recalls. 2022-04-28 19:49:13


The complaint was released Thursday by Representative Rosa DeLoro, D-Connecticut, chair of the House Appropriations Committee. The congresswoman said she received the complaint this week and described her allegations as “extremely troubling.”

Abbott recalled three popular brands of infant formula powder in February after reports that four children drinking formula at the facility had developed a rare and serious infection caused by the bacterium Cronobacter sakazakii. Two children died. Production at the facility has halted and remains temporarily suspended.

on April 15 statment Abbott, which was posted on the company’s website, said it is working closely with the Food and Drug Administration to restart the plant.

The former employee, who worked for Abbott Laboratories’ Sturgis, stated that he saw the records were fraudulent “on multiple occasions” and, in most cases, the information was not disclosed when it should have been.

For example, according to the complaint, the employee reported observing events that were underestimated or inaccurately described “to limit or avoid oversight” and “fail to keep accurate maintenance records.”

After several samples from a batch of infant formula were found to contain microorganisms, or “micro,” whistleblowers claim that the factory performed a time code removal, as the formula was produced around the same time as the contaminated samples were disposed of, but the Producing the formula outside of these time codes to be sold without additional testing to ensure it is safe for consumption.

The complaint says that in 2020, the product was not pulled from the market even after management realized there was a packaging integrity issue, an issue the reporter said should have caused the manufacturer to take the product off shelves and conduct more testing.

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The company said in statment Thursday. “We enable our employees to identify and report any issues that may jeopardize the safety or quality of our products, which come before any other considerations.

“With regard to the document issued by Congresswoman Rosa DeLoreau (D-Conn.), this former employee was fired for serious violations of Abbott’s food safety policies. Following the dismissal, the former employee, through his attorney, developed, new, and escalated 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.

According to the complaint, “Others also raised concerns, some with management but more often among colleagues at Sturgis. Owing to the overwhelming fear of retaliation, few were as outspoken as the complainant.” “Ultimately despite his impressive employment record at Abbott and elsewhere, the complaint was terminated based on his repeated escalation of compliance concerns.”

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

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The complaint also says managers may have “sanitized” the files before they got to FDA inspectors. “Active and even celebrated efforts were made during and after the 2019 FDA review to prevent reviewers from learning about certain events believed to be related to the discovery of microbes in infant formula at the Sturgis website,” the document says. It goes on to claim that Sturgis continued to allow permissive 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 Appropriations Committee hearing minutes. “We need to know exactly who in the company was aware of this failure and the alleged attempts to hide this information from the Food and Drug Administration.

“I am equally concerned that the FDA’s reaction to this report has been too slow,” DeLauro said, noting that the agency received the whistleblower’s statement in October but did not meet the man until December nor did a personal inspection of the Site. Sturgis facility through January.

Delro Asked The Inspector General of the US Department of Health and Human Services to examine the response of the Food and Drug Administration.

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

“We know there have been questions about the timeline related to the recall of Abbott Nutrition Infant Formula. However, this remains an open investigation with many moving parts. Our highest priority is to ensure that any product recalled that was produced at our Sturgis, Michigan facility has been removed. From the market We are continuing to investigate and will continue to update our consumer alert if additional consumer safety information becomes available.

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“Once the immediate risks to the public are addressed, we will conduct a review, and as described in the recently released Foodborne Disease Outbreak Response Improvement Plan, we will build performance metrics across the FDA’s Food Program to better assess the timing and effectiveness of outbreaks and regulatory investigations.” .

Cronobacter infection in infants almost always occurs by drinking contaminated infant formula. Cronobacter can be introduced during manufacture and also after formula packaging has been opened at home.

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

Abbott Nutrition is also the exclusive supplier to many of the state’s 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 several shortcomings in the facility. FDA test Cronobacter sakazakii was found on equipment at the factory.

In an initial evaluation, the FDA determined that Abbott had not taken steps to prevent contamination of products during manufacturing.

at statment Abbott, which was posted on its website in March, said it is reviewing the Food and Drug Administration’s notes. “We take this very seriously and are working closely with the Food and Drug Administration to implement corrective actions.”

“It is important to note that neither Cronobacter sakazakii nor Salmonella was found in any of our consumer-delivery product tests. In addition, the unique genetic makeup of Cronobacter sakazakii microbes found in the non-productive contact areas of the Sturgis facility did not match the Cronobacter sakazakii microbes from the Sturgis facility,” the statement said. reported cases.

“A comprehensive review of all available data indicates that infant formula produced at the Sturgis facility is not likely to have been the source of infection in the reported cases and that there was no outbreak caused by products from the facility,” Abbott added in a statement Thursday.