Abbott Laboratories, whose Michigan infant formula plant was shut down last year due to contamination problems, is being investigated by the Department of Justice.
The study comes nearly a year after the plant was first shut down, adding to a nationwide formula shortage that worries parents and caregivers.
Abbott is just one of four companies that make 90% of formula in the US – Gerber, Perrigo and Reckitt being the others.
A company spokesman said Abbott was “cooperating fully” with the federal government.
Here’s a timeline of how the baby formula maker got to this point:
ABBOTT is recalling several ready-to-feed liquid infant formulas
Food and Drug Administration (FDA) officials received a whistleblower complaint alleging multiple safety violations at a Michigan plant. The complaint alleges that employees falsified records and that the formula was not properly tested before it was dispensed.
Although the complaint was reviewed at the end of October, an interview with the employee did not take place until December.
FDA Commissioner Dr. Robert Califf later took issue with House lawmakers on why the FDA’s investigation of the complaint was taking so long.
The FDA is sending inspectors to the Sturgis facility and will begin an investigation on January 31st.
In early February, Abbott initiated a recall of certain Similac, Alimentum and EleCare powdered baby foods manufactured at the Sturgis plant and ceased operations at the facility.
ABBOTT Recalls SIMILACI, OTHER Infant Formulas After 4 Illnesses
In a separate notice, the FDA warned consumers not to use Abbott’s recalled formula because it investigated four bacterial infections among infants who consumed the herbal powder formula. All four were hospitalized, two died. The first of these incidents was reported to the FDA in September.
The FDA released the results of an inspection of the plant that showed Abbott was not maintaining clean surfaces used in the production and processing of the powder formula. In addition, inspectors found a history of contamination with bacteria known as cronobacter, including eight samples between the fall of 2019 and February 2022.
Although inspectors found several violations at the plant, Abbott said its products were not directly linked to infections involving different bacterial strains.
Abbott submitted a response and corrective action plan to the FDA on April 8 following the inspection.
Even before that response, the company said it had “begun 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 for water, cleaning and maintenance. . procedures in the facility.
ABBOTT’S TROUBLE BABY FORMULA FACTORY IS BACK IN BUSINESS
The company also said it was “immediately making adjustments to address the items raised in the FDA’s post-inspection observations.”
On April 28, Abbott announced that none of the Abbott formula distributed to consumers had tested positive for Cronobacter sakazakii or salmonella.
“Testing of stored products by Abbott and the FDA for Cronobacter sakazakii and/or Salmonella was negative. No Salmonella was detected at the Sturgis facility during the investigation,” the company said in a statement.
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The company said Cronobacter sakazakii, which was found in environmental testing during the investigation, came into contact with non-product from the Sturgis facility and was “not linked to the two existing patient samples or any other known infant illness.”
Abbott warned that it could take at least two months to get the new products on store shelves.
Meanwhile, retailers including Target, CVS and Walgreens have imposed restrictions on purchases of baby formula as the nationwide shortage worsens.
Abbott restarted production at the plant on June 4, but was forced to halt production due to severe weather.
Abbott halted production of its EleCare specialty formulation to assess storm damage and to clean and resanitize the plant. The company said it expects production to be delayed for several weeks.
ABBOTT SAYS IT WILL BE AT LEAST TWO MONTHS BEFORE THE PRIVATE PLANT BABY FORMULA HAS BEEN ON SHELVES.
Abbott resumed production on July 1. The company started with the production of EleCare and later moved into the production of some metabolic formulas.
The company has resumed production of Similac infant formula at its Sturgis facility. Abbott estimated it would take six weeks for the product to ship to retail locations.
The company said it could supply the U.S. with more than 8 million pounds of infant formula during the month than it produced in August 2021.
The Justice Department’s consumer protection division began investigating the conduct at the Sturgis plant that led to its closure. The study was first reported by The Wall Street Journal.
The Associated Press contributed to this report.