Contaminated formula: Department of Justice opens criminal investigation of Abbott after infant deaths


Abbott's manufacturing facility in Sturgis, Michigan, on May 13, 2022.
Zoom in / Abbott’s manufacturing facility in Sturgis, Michigan, on May 13, 2022.

The Justice Department’s Consumer Protection Branch has opened a criminal investigation into the conduct of Abbott Laboratories, one of the nation’s largest formulation makers, amid a contamination scandal and Ongoing shortage nationwide.

The existence of the investigation was first reported by The Wall Street Journal. Although the Department of Justice does not comment on this, an Abbott spokesperson said the department has informed them of the investigation and that the company is “cooperating fully.”

Federal regulators last year found numerous violations and “grossly unsanitary” conditions at the Abbott Sturgis, Michigan, plant, the nation’s largest food processing plant. Organizers had previously received reports that at least four children who drank formula made at that facility developed serious infections from the bacteria. Cronobacter sakazakii, which was also detected at the plant. Two of the children died.

The FDA also received a whistleblower complaint of alleged safety violations, falsification of records, and cover-ups at the facility. But it took several months for that complaint to reach top FDA officials, during which time one child died and others became ill. The FDA’s clumsy handling of the complaint sparked and sparked a backlash from lawmakers Agency external review.

Meanwhile, Abbott denied that his formula was responsible for infant illnesses and deaths. The company argued that strains C. sakazakii found at their Sturgis facility does not genetically match a strain found in an open formula container from one of the sick infants’ homes, that matches the strain that affected that infant, or a strain found with another infant disease. (There is no genetic data on the strains that affected the other two infants.) Food safety experts at the Food and Drug Administration rejected Abbott’s argumentindicating that multiple strains of C. sakazakii They were found at the factory and sampling at the facility could have easily missed the other strains. They also note that the lack of bacteria seen in testing of the company’s final product is not conclusive; Testing small quantities of batches of formula totaling hundreds of thousands of pounds in total will almost always miss low level contamination.

“unwilling or unable”

An FDA investigation led to the closure of the Sturgis facility this past February, exacerbating a nationwide shortage of formula. Parents were left facing bare shelves in stores as they desperately sought food for their children, some requiring special formulations. Federal officials scrambled to increase supply, waive regulations and tariffs, and oversea formula. Although the shortage has eased somewhat, the supply has yet to recover. Reckitt Benckiser, the manufacturer of Enfamil, said in December that it expected a shortage extend in the spring.

To safely restart the Sturgis plant, Abbott entered into a legal agreement called a approval decreewith the Food and Drug Administration last May laying out strict steps Abbott would need to take to safely reopen the facility.

in accompanying complaintThe Department of Justice identified a series of violations and failures found at the Sturgis facility, including that the company’s own tests revealed persistent contamination. C. sakazakii at the facility and that the Food and Drug Administration had previously issued warnings.

“Continuing deficiencies in manufacturing conditions and practices at Defendants’ facilities demonstrate that Defendants were unwilling or unable to implement sustained corrective actions to ensure the safety and quality of processed foods for children, a consumer group that is particularly vulnerable to foodborne pathogens,” the department wrote. .

The Wall Street Journal reports that the administration has successfully sued other food companies and their executives for bringing tainted food to market. In 2020, for example, the ice cream company Blue Bell paid $19 million He pleaded guilty to shipping tainted ice cream linked to A.J Listeria The outbreak that claimed three lives. In 2015, it was the former owner of the American Peanut Corp, Stuart Parnell sinner On many charges related to salmonella which claimed nine lives and sickened more than 700 others. He was sentenced to 28 years in prison.



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