The Abbott Infant Formula Crisis: A Timeline of What Led to the Department of Justice Investigation

Abbott Laboratories, whose infant formula plant in Michigan was closed last year due to contamination problems investigated by the Ministry of Justice.

The probe comes nearly a year after the factory first closed, exacerbating a nationwide formula shortage that has left parents and caregivers scrambling.

Abbott is one of four other companies – Gerber, Perego and Reckitt – that produce 90% of the formula in the United States.

A company spokesperson said Abbott “cooperates fully” with the federal government.

Here is the timeline of how the infant formula maker got to this point:

Abbott mentions several ready-to-feed liquid infant formulas

October 2021

Officials at the Food and Drug Administration (FDA) received a whistleblower complaint alleging numerous safety violations at the Michigan plant. The complaint included allegations that employees falsified records and failed to properly test the formula before releasing it.

December 2021

Although the complaint was reviewed in late October, an interview with the employee did not take place until December.

A truck trailer outside the Abbott Feed plant in Sturgis, Michigan, May 19, 2022. (Matthew Hatcher/Bloomberg via/Getty Images)

Food and Drug Administration Commissioner Dr. Robert Calif was later Roasted by legislators in the House of Representatives On why the FDA took so long to investigate the complaint.

January 2022

The FDA is sending inspectors to the Sturgis facility and starting an investigation on January 31.

February 2022

In early February, Abbott began recalling some Similac, Alimentum, and EleCare powdered infant formula that had been made at the Sturgis plant, and ceased operations at the facility.

mentions abbott similac, other infant formulas after 4 reported illnesses

In a separate notice, the Food and Drug Administration (FDA) warned consumers not to use the recalled Abbott’s formula because it is investigating four cases of bacterial infections among infants who were Consume the powdered formulation of the plant. All four were taken to hospital, and two died. The first of these cases was reported to the FDA in September.

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March 2022

The US Food and Drug Administration (FDA) has revealed the results of its examination of the plant, that showed In part, this is because Abbott did not maintain and handle the clean surfaces used in the production and handling of the powdered formula. In addition, inspectors found a history of contamination with the bacteria, known as cronobacter, including eight cases between fall 2019 and February 2022.

While inspectors uncovered numerous violations at the plant, Abbott stated that its products were not directly linked to the infection, which included various bacterial strains.

April 2022

Abbott submitted a response and corrective action plan to the Food and Drug Administration on April 8 after the examination.

Abbott Laboratories facility reopens in Sturgis, Michigan

The Abbott Laboratories facility where dozens of the recalled dried infant formula types were manufactured, in Sturgis, Michigan, on May 20, 2022. (Eric Cox/file photo/Reuters Images)

Even before this response, the company said it had already begun “working to implement improvements and take corrective measures,” including reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating protocols related to water, cleaning and maintenance. procedures in the facility.

Abbott baby formula factory back in business

The company also said it “promptly implemented corrections to address the items raised by the FDA in its notes provided at the conclusion of the inspection.”

On April 28, Abbott announced that none of the Abbott formula distributed to consumers had tested positive for Cronobacter sakazakii or Salmonella.

baby milk

Baby formula is seen on Walmart shelves in Raleigh, North Carolina, on June 2, 2022. (Arriana Mclymore / File Photo / Reuters Photos)

“Products withheld by Abbott and the Food and Drug Administration (FDA) tested positive for Cronobacter sakazakii and/or Salmonella all came back negative. No salmonella was found at the Sturgis facility during the investigation,” the company said in a statement.

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The company said Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas at the Sturgis facility “and has not been linked to the two available patient samples or any other known infant disease.”

May 2022

Abbott warned that it could take at least two months to get new products on store shelves.

At the same time, retailers imposed, including Target, CVS, and Walgreens Purchase restrictions on infant formula as shortages worsen nationwide.

June 2022

Abbott resumed production at the plant on June 4, but had to pause production due to inclement weather.

Empty shelves, lack of infant formula

Shelves stocked with infant formula are usually mostly empty at a store in San Antonio, May 10, 2022. (Eric Jay/AP Newsroom)

Abbott has discontinued its specialized EleCare formula to assess storm damage and to clean and re-sanitize the plant. The company said it expects to delay production by a few weeks.

Abbott says it will be at least two months before baby formula is off the shelves at the closed factory.

July 2022

Abbott resumed production on July 1. The company started with EleCare and later moved into some metabolic formulas.

August 2022

The company has reintroduced Similac infant formula at its Sturgis facility. Abbott has estimated that it will take up to six weeks for the product to start shipping to retail locations.

Over the course of the month, the company said, it will be able to supply the United States with more than 8 million pounds of infant formula, which is more than it produced in August 2021.

January 2023

The Consumer Protection Branch of the Department of Justice has begun looking into the behavior at the Sturgis plant that led to the plant closing. The Wall Street Journal first reported the investigation.

The Associated Press contributed to this report.

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