Infant formula crisis at Abbott: A timeline of what led to a DOJ investigation

Abbott Laboratories, whose Michigan infant formula plant was closed last year due to contamination concerns, is investigation by the Department of Justice.

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

Abbott is just one of four companies – Gerber, Perrigo and Reckitt are the others – that produce 90% of the formula in the United States.

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

Here’s the timeline of how the formula maker got to this point:

ABBOTT RECALLS SEVERAL READY-TO-FEED LIQUID INFANT FORMULA

October 2021

Food and Drug Administration (FDA) officials have 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 investigated in late October, an interview with the employee did not take place until December.

Abbott Michigan

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

FDA Commissioner Dr. Robert Califf was later grilled by House lawmakers why it took the FDA so long to investigate the complaint.

January 2022

The FDA sends inspectors to Sturgis facilities and opens an investigation on January 31.

February 2022

In early February, Abbott initiated a recall of certain Similac, Alimentum and EleCare powdered infant formulas manufactured at the Sturgis plant and ceased operations at the plant.

ABBOTT RECALLS SIMILAC, OTHER BABY FORMULA AFTER 4 REPORTED ILLNESSES

In a separate advisory, the FDA warned consumers not to use Abbott’s recalled formula as it investigates four bacterial infections in infants that consumed powdered preparation of the plant. All four were hospitalized and two died. The first of these cases was reported to the FDA in September.

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March 2022

The FDA revealed the results of its inspection of the factory, who showed in part because Abbott failed to keep the surfaces used in the production and handling of the powder formula clean. Additionally, inspectors found a history of contamination with the bacteria, known as cronobacter, including eight cases between fall 2019 and February 2022.

While inspectors found several violations at the factory, Abbott said its products were not directly linked to the infections, which involved different bacterial strains.

April 2022

Abbott submitted a response and corrective action plan to the FDA on April 8 following the inspection.

Abbott Laboratories factory reopens in Sturgis, Michigan

The Abbott Laboratories plant where dozens of types of recalled powdered baby formula were manufactured, in Sturgis, Michigan on May 20, 2022. (Eric Cox/File Photo/Reuters Photos)

Even before this response, the company said it had already “begun implementing improvements and taking corrective actions”, including reviewing and updating education, training and safety procedures. for employees and visitors, as well as updating water, cleaning and maintenance protocols. establishment procedures.

ABBOTT’S TROUBLED BABY FORMULA FACTORY BACK IN BUSINESS

The company also said it “immediately implemented corrections to address the issues raised by the FDA in its observations provided at the conclusion of the inspection.”

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

Baby formula

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

“Tests of products retained by Abbott and the FDA for Cronobacter sakazakii and/or Salmonella were all negative. No Salmonella was found at Sturgis facilities during the investigation,” the company said in a statement. communicated.

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The company said the Cronobacter sakazakii that was found during environmental testing during the investigation was in non-product contact areas of the Sturgis facility “and was not linked to the two samples of available patients or any other known childhood illness”.

May 2022

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

At the same time, retailers including Target, CVS and Walgreens have imposed purchase limitations on infant formula as the national shortage worsened.

June 2022

Abbott restarted production at the factory on June 4, but was forced to suspend production due to extreme weather conditions.

Empty shelves Shortage of infant formula

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

Abbott halted production of its EleCare specialty formula to assess storm damage and to clean and disinfect the plant. The company said it expected production to be delayed for a few weeks.

ABBOTT SAYS IT WILL BE AT LEAST TWO MONTHS BEFORE CLOSED FACTORY BABY FORMULA HITS THE SHELVES

July 2022

Abbott resumed production on July 1. The company started production of EleCare and later moved into the production of certain metabolic formulas.

August 2022

The company restarted production of Similac infant formula at the Sturgis plant. Abbott estimated it would take six weeks for the product to begin shipping to retail outlets.

The company said throughout the month it would be able to supply the United States with more than 8 million pounds of infant formula, more than it produced in August 2021.

January 2023

The Justice Department’s consumer protection arm has begun investigating conduct at the Sturgis plant that led to its closure. The Wall Street Journal first reported the investigation.

The Associated Press contributed to this report.

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