Abbott Laboratories reportedly faces U.S. criminal probe - CNBC

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Person's hand holding a bottle of Similac baby formula from Abbott Laboratories in Lafayette, California, May 13, 2022.

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Abbott Laboratories is under investigation by the Department of Justice, NBC News confirmed on Saturday, citing a spokesperson for the company.

"DOJ has informed us of its investigation and we're cooperating fully," according to spokesman Scott Stoffel.

The Wall Street Journal first reported that Abbott Labs was under criminal investigation related to the company's manufacturing of infant formula, citing "people familiar with the matter."

NBC News has not confirmed the focus of the investigation.

Abbott voluntarily shut down production of its Sturgis, Michigan, 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.

As NBC News previously reported, federal investigators were unable to definitively determine the source or sources of a rare bacteria called Cronobacter that sickened four infants, two of them now dead, who all consumed powdered formula made at Abbott's Michigan factory.

The company signed a consent decree with the federal government in May that laid out what it would do before re-opening its plant.

A Food and Drug Administration press release that accompanied the consent decree described DOJ's complaint filed on behalf of the FDA: "…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, 2022.

Abbott said in a previous statement provided to NBC News that it "continue[s] to enhance our manufacturing and quality processes to ensure that our products remain free of Cronobacter Sakazakii" and has "already begun implementing corrective actions and enhancements at the facility."

The company also said that the lack of a genetic match between sick infants and the formula confirmed its own internal testing showing there was no link and said it has not found the bacteria in any of its distributed products.

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