Abbott Laboratories is being investigated by U.S. authorities for possible criminal conduct that led to last year's shutdown of an infant formula plant in Sturgis, Michigan, due to product contamination, according to the company.
The U.S. Department of Justice (DOJ) is probing the matter, a spokesperson told news outlets.
"DOJ has informed us of its investigation and we’re cooperating fully,” the Abbott spokesperson said.
Abbott didn't respond to a request for more information. DOJ officials didn't return an inquiry.
Abbott, one of the largest U.S. formula manufacturers in the country, issued a voluntary recall in February 2022 after the U.S. Food and Drug Administration warned Americans not to use some products made at one of the company's plants in Sturgis. An investigation uncovered unsanitary conditions there following a whistleblower complaint.
Dr. Robert Califf, Food and Drug Administration commissioner, said during a congressional hearing that the investigation results "were shocking," describing conditions he said were "egregiously unsanitary."
Regulators discovered the presence of Cronobacter sakazakii, a bacteria that can contaminate dry products such as infant formula powder, at the facility. The U.S. Centers for Disease Control and Prevention opened a probe into multiple cases, including several deaths, potentially linked to the contamination. Authorities said they were unable to find a definitive connection between the illnesses and Abbott's products. Abbott has said that none of the formula it distributed tested positive for Cronobacter.
The Federal Food, Drug, and Cosmetic Act of 1938 prohibits "adulterated food," or food that "contains any poisonous or deleterious substance which may render it injurious to health," with some exceptions. People or companies that enter adulterated food into "interstate commerce "can be prosecuted under the law.
Examples of interstate commerce include selling a product, shipping it to another state, or contracting with another company or person to ship the good to another state.
The plant shutdown lead to baby formula shortages that plagued new parents for months.
The Sturgis plant reopened in mid-2022 after U.S. authorities and Abbott agreed to a plan outlining steps that the company needed to take to correct deficiencies.
“We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America,” Abbott said as the plant reopened.
“We will ramp production as quickly as we can, while meeting all requirements. We’re committed to safety and quality and will do everything we can to re-earn the trust parents, caregivers and health care providers have placed in us for 130 years.”