Abbott Laboratories, whose baby formula plant in Michigan was shut down last year due to contamination issues, is being investigated by the Justice Department.
The probe comes nearly a year after the plant was first shut down, exacerbating the nationwide formula shortage that 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 U.S.
A company spokesperson said Abbott is “cooperating fully” with the federal government.
Here is the timeline of how the baby formula maker got to this point:
Officials at the Food and Drug Administration (FDA) received a whistleblower complaint alleging numerous safety violations at the Michigan plant. The complaint included claims that employees had falsified records and failed to properly test the formula before releasing it.
Although the complaint was reviewed in late October, an interview with the employee didn’t take place until December.
FDA Commissioner Dr. Robert Califf was later grilled by House lawmakers on why it took so long for the FDA to investigate the complaint.
The FDA sends inspectors to the Sturgis facility and begins an investigation on Jan. 31.
In early February, Abbott initiated a recall of certain Similac, Alimentum and EleCare powdered infant formulas that were manufactured at the Sturgis plant, and ceased operations at the facility.
In a separate notice, the FDA warned consumers not to use Abbott’s recalled formula as it investigated four bacterial infections among infants who consumed powdered formula from the plant. All four were hospitalized and two died. The first of those cases was reported to the FDA in September.
The FDA revealed findings of its inspection of the plant, which showed in part that Abbott didn’t maintain clean surfaces used in producing and handling the powdered formula. Additionally, inspectors found a history of contamination with the bacteria, known as cronobacter, including eight instances between fall 2019 and February 2022.
While inspectors uncovered several violations at the plant, Abbott has stated that its products have not been directly linked to the infections, which involved different bacterial strains.
Abbott submitted a response and corrective action plan to the FDA on April 8 following the inspection.
Even before this response, the company said it had already “begun working to implement improvements and take corrective action,” including reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating protocols regarding water, cleaning and maintenance procedures at the facility.
The company also said it “immediately implemented corrections to address the items that the FDA raised in its observations provided at the conclusion of the inspection.”
On April 28, Abbott announced that none of the Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or salmonella.
“Testing of retained products by Abbott and FDA 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.
The company said the Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the Sturgis facility “and has not been linked to the two available patient samples or any other known infant illness.”
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, imposed purchasing limitations on baby formula as the nationwide shortage worsened.
Abbott restarted production at the plant on June 4, but was forced to pause production due to severe weather.
Abbott stopped production of its EleCare specialty formula to assess damage caused by a storm and to clean and re-sanitize the plant. The company said it expected production to be delayed for a few weeks.
Abbott resumed production on July 1. The company began production of EleCare and later moved on to producing some metabolic formulas.
The company restarted Similac infant formula production at the Sturgis facility. Abbott estimated that it would take six weeks for the product to begin shipping to retail locations.
The company said that throughout the month it will be able to supply the U.S. with more than 8 million pounds of infant formula, which is more than what it produced in August 2021.
The Justice Department’s consumer protection branch began looking into the conduct at the Sturgis plant that led to its shutdown. The Wall Street Journal first reported the investigation.
The Associated Press contributed to this report.