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Abbott Laboratories reportedly faces U.S. criminal probe

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

Smith Collection | Gado | Archive Photos | Getty Images

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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Business

Abbott Laboratories directs employees to dispose of rapid COVID-19 test materials

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Employees at Abbott Laboratories, which makes rapid COVID-19 tests, were instructed in June and July to start destroying BinaxNOW test materials amid declining sales, The New York Times reported.

The BinaxNOW antigen test, which can provide COVID-19 results within 15 minutes, was popular earlier in the pandemic as a way for people to quickly learn whether they had the coronavirus, and Abbott once partnered with the White House under former President TrumpDonald TrumpOvernight Defense: Afghan flights restart as Biden vows to complete evacuation Trump says he ‘single-handedly’ picked Alabama for Space Command, contradicting Pentagon Overnight Health Care: Battle over masks in Florida escalates as two school districts given 48 hours to comply MORE.

The antigen tests are less reliable than the PCR tests, which tend to provide results within a few days.

The Times reported that sales for the rapid test fell in the spring as cases started to decline amid a nationwide vaccine rollout.

A Centers for Disease Control and Prevention announcement issued in May that vaccinated people did not need to continue being tested even if they had been exposed to COVID-19 added to the trouble, with fewer people needing tests.

“The numbers are going down,” a site manager, Andy Wilkinson, reportedly told employees who were ultimately laid off, regarding testing demands. “This is all about money.”

As a result, hundreds of thousands of test cards used for the rapid tests were disposed of, according to a few employees who spoke on condition of anonymity to the Times.

However, now Abbott has a new problem: being able to keep up with a renewed demand for the rapid tests as the delta variant spreads through vulnerable and unvaccinated communities, creating a new surge of COVID-19 cases. 

The Times reported that thousands of companies were reportedly told by Abbott that it would not be able to supply them with rapid tests immediately while it struggles to rehire workers it had previously let go.

Aly Morici, director of public affairs at Abbott, told the Times in an emailed statement that it was  “difficult to scale up on a dime, but we’re doing so again” and anticipated there would be some “supply constraints” over the next couple of weeks.

However, there are still questions regarding why test cards were eliminated. 

Abbott CEO and President Robert Ford told the Times in an interview that test cards were being disposed of because of their shelf life, though the news outlet reported that photos they had of test cards being thrown away in June and July showed they were not set to expire for at least seven months.

In a statement after the Times story was published, Abbott issued a statement maintaining that the company had not “destroyed any finished BinaxNOW product, nor have we destroyed any usable test components needed by the market that could have been donated.”

The company argued that it had also chosen to store some of its materials for future use “in the event that we needed to scale back up, which is exactly what’s happening now.”



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