The DOJ spent years investigating Abbott Laboratories over how it managed a baby formula facility. Some prosecutors believed they had enough to charge the company, but senior officials opted for a civil settlement.

The Justice Department's multi-year criminal investigation into Abbott Laboratories regarding its Sturgis, Michigan infant formula plant has concluded without criminal charges being filed against the company, its executives, or employees. This decision comes despite some federal prosecutors and FDA investigators believing there was sufficient evidence to pursue criminal charges related to the unsanitary conditions that led to a national infant formula shortage and infant illnesses. Instead, the DOJ opted for a civil settlement with Abbott in May 2022, which allowed the plant to reopen under a consent decree.

The investigation centered on serious sanitation problems, including Cronobacter sakazakii bacteria found at the plant, a leaking roof, and pooled water near production lines, as well as allegations of falsified documents and covered-up safety violations by a whistleblower. Four infants fell ill with Cronobacter sakazakii, and two died, although no direct link between the plant's bacteria strains and the infant illnesses was definitively established by federal officials. The FDA's inspection in early 2022 uncovered "shocking" conditions, leading to a major recall of Similac and other infant formulas and the plant's temporary closure.

The decision not to pursue criminal charges has drawn criticism, with some legal experts and consumer advocates suggesting it reflects a reluctance by the DOJ to hold major corporations criminally accountable in food safety cases, especially when a direct link between a company's actions and specific deaths or illnesses can be challenging to prove beyond a reasonable doubt. The DOJ's consumer-protection branch, which led the probe, has successfully prosecuted other food companies and executives in the past for introducing contaminated food. However, this case highlights the complexities of such prosecutions, particularly when it involves large, influential corporations.

Abbott has consistently denied criminal wrongdoing and stated its full cooperation with the DOJ's investigation. The company entered into a consent decree with the FDA in May 2022, outlining strict steps for remediation and safe operation. Following the plant's closure, the Biden administration took measures like airlifting formula and waiving regulations to address the severe national shortage, which was exacerbated by the incident, as the Sturgis plant produced about one-fifth of the nation's infant formula supply.