Abbott faces US criminal probe over baby formula
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Abbott Laboratories is under investigation by the U.S. Department of Justice, the company confirmed Friday, almost a year after it shut down a Michigan baby-formula plant after illnesses were reported.
Abbott did not specify what aspect of the company is under Justice Department scrutiny.
“DOJ has informed us of its investigation and we’re cooperating fully,” an Abbott spokesperson said in a statement to NBC News.
The Wall Street Journal reported earlier Friday that the Justice Department was investigating conduct at Abbott’s plant in Sturgis, Michigan, citing people familiar with the matter who it did not name. NBC News has not independently confirmed the nature of the investigation. The Department of Justice did not immediately respond to a request for comment from NBC News.
Abbott voluntarily shut down production at its Sturgis infant formula manufacturing plant on Feb. 17, 2022, after infants who consumed formula made at the plant became sick.
The shutdown contributed to a nationwide infant formula shortage.
Four infants, two of whom died, were sickened by a rare bacteria after consuming powdered formula made at Abbott’s Michigan factory.
Federal investigators could not definitively determine the source or sources of the bacteria, Cronobacter sakazakii, which can cause severe illness.
The company signed a consent decree with the federal government in May that laid out what it would do before re-opening its plant.
The Food and Drug Administration said when the proposed consent decree was announced that “the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements.”
Production at the Michigan factory, which makes three of the country’s most popular brands — Similac, Alimentum and EleCare — resumed in June.
Abbott Labs previously said that it “continue[s] to enhance our manufacturing and quality processes to ensure that our products remain free of Cronobacter Sakazakii” and had “already begun implementing corrective actions and enhancements at the facility.”
The company also said the lack of a genetic match between sick infants and the formula confirmed its own internal testing showing there was no link, and it said it has not found the bacteria in any of its distributed products. baby
formula
Questions & Answers
Q.What specifically is the U.S. Department of Justice investigating at Abbott?
What specifically is the U.S. Department of Justice investigating at Abbott?
Abbott has not specified what aspect of the company is under Justice Department scrutiny. However, The Wall Street Journal reported the investigation is looking into conduct at Abbott's plant in Sturgis, Michigan.
Q.When did Abbott shut down its Sturgis plant and when did production resume there?
When did Abbott shut down its Sturgis plant and when did production resume there?
Abbott voluntarily shut down production at its Sturgis plant on February 17, 2022. Production at the Michigan factory resumed in June of the same year.
Q.What was the government's allegation about the formula produced at the Sturgis facility?
What was the government's allegation about the formula produced at the Sturgis facility?
The government alleged that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated. This was because they were reportedly made under insanitary conditions and violated current good manufacturing practice requirements.
Q.What actions has Abbott taken since the shutdown to improve its manufacturing process?
What actions has Abbott taken since the shutdown to improve its manufacturing process?
Abbott signed a consent decree with the federal government outlining actions needed before re-opening. The company also stated it continues to enhance manufacturing and quality processes and has implemented corrective actions and enhancements at the facility.
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