Abbott Laboratories, whose Michigan baby food plant closed last year due to contamination concerns, is under investigation by the Justice Department.
The probe comes nearly a year after the factory was first shut down, exacerbating the nationwide shortage of formulas that left parents and carers confused.
Abbott is just one of four companies – Gerber, Perrigo and Reckitt being the others – that produce 90% of the formula in the US
A company spokesperson said Abbott is “fully cooperating” with the federal government.
Here’s the timeline of how the baby food maker got to this point:
ABBOTT REMEMBERS DIFFERENT CONVENIENT NOURISHING LIQUID BABY FORMULA
Food and Drug Administration (FDA) officials received a whistleblower complaint alleging numerous safety violations at the Michigan plant. The complaint included allegations that employees falsified data and failed to properly test the formula prior to release.
Although the complaint was assessed at the end of October, a meeting with the employee did not take place until December.
FDA Commissioner Dr. Robert Califf was later questioned by House lawmakers about why it took so long for the FDA to investigate the complaint.
The FDA is sending inspectors to the Sturgis facility and beginning an investigation on Jan. 31.
In early February, Abbott began 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 FORMULAS AFTER 4 REPORTED DISEASES
In a separate message, the FDA warned consumers not to use Abbott’s recalled formula as it investigated four bacterial infections in infants who consumed the plant’s powdered formula. All four were hospitalized and two died. The first of those cases was reported to the FDA in September.
The FDA revealed findings from its inspection of the plant, which showed in part that Abbott failed to keep the surfaces used in manufacturing and handling the powder formula clean. 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 several violations at the plant, Abbott has stated that its products are not directly related to the infections, which involved several strains of bacteria.
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 was already “starting work on implementing improvements and taking 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 in the facility.
ABBOTT’S TRUSTED BABY FORMULA FACTORY BACK IN BUSINESS
The company also said it “immediately made corrections to address the points raised by the FDA in its comments at the end of the inspection.”
On April 28, Abbott announced that none of the Abbott formulas distributed to consumers tested positive for Cronobacter sakazakii or salmonella.
“Testing of retained products by Abbott and the FDA for Cronobacter sakazakii and/or Salmonella was all negative. No Salmonella was found in the Sturgis facility during the investigation,” the company said in a statement.
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The company said the Cronobacter sakazakii found in environmental testing during the study was in non-product contact areas of the Sturgis facility “and is not linked to the two available patient samples or any other known childhood disease.”
Abbott warned that it could take at least two months for new products to hit store shelves.
At the same time, retailers including Target, CVS and Walgreens imposed purchasing restrictions on baby food as the nationwide shortage worsened.
Abbott resumed production at the plant on June 4, but had to suspend production due to severe weather.
Abbott halted production of its EleCare specialty formula to assess storm damage and to clean and re-sanitize the plant. The company said it expects production to be delayed by a few weeks.
ABBOTT SAYS IT WILL BE AT LEAST TWO MONTHS BEFORE SHUTTERED PLANT BABY FORMULA HITS
Abbott resumed production on July 1. The company started out with the production of EleCare and later went on to produce some metabolic formulas.
The company restarted production of Similac infant formula at its Sturgis plant. Abbott estimated it would take six weeks to ship the product to retail locations.
The company said it will be able to supply the US with more than 8 million pounds of infant formula throughout the month, which is more than what it produced in August 2021.
The Department of Justice’s consumer protection division began an investigation into the behavior at the Sturgis plant that led to its closure. The Wall Street Journal first reported on the investigation.
The Associated Press contributed to this report.