Abbott Laboratories reportedly facing US criminal investigation

A person’s hand holding a bottle of Similac baby formula from Abbott Laboratories in Lafayette, California on May 13, 2022.

Smith collection | gado | Stock photos | Getty Images

Abbott Laboratories is being investigated by the Justice Department, NBC News confirmed on Saturday, citing a company spokesperson.

“The DOJ has notified us of its investigation and we are cooperating fully,” spokesman Scott Stoffel said.

The Wall Street Journal first reported that Abbott Labs was the subject of a criminal investigation related to the company’s manufacture of infant formula, citing “people familiar with the matter”.

NBC News has not confirmed the subject of the investigation.

Abbott voluntarily shut down production at its infant formula manufacturing plant in Sturgis, Michigan on Feb. 2. On December 17, 2022, after infants consuming factory-made infant formula fell ill. The shutdown contributed to a nationwide shortage of infant formula.

As NBC News previously reported, federal investigators have been unable to definitively determine the source or sources of a rare bacteria called Cronobacter that sickened four infants, two of whom are now dead, all of whom have consumed infant formula made at Abbott’s Michigan plant.

The company signed a consent decree with the federal government in May that spells out what it would do before reopening its plant.

A Food and Drug Administration press release that accompanied the consent decree described the complaint filed by the DOJ on behalf of the FDA: “…the government alleges that powdered infant formula manufactured at Abbott Nutrition’s facilities in Sturgis have been tampered with because they were manufactured under unsanitary conditions and in violation or current good manufacturing practice requirements.”

Production at the Michigan plant, 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 she “continues[s] to improve our manufacturing and quality processes to ensure that our products remain free of Cronobacter Sakazakii” and has “already begun to implement corrective actions and improvements in the facility”.

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

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