Abbott Laboratories is under investigation by the U.S. Department of Justice (DOJ). The investigation follows the DOJ’s probe into the deaths of two infants last year who allegedly consumed infant formula produced at Abbott’s Sturgis plant in Michigan. The facility was shut down through June 2022 to address deficiencies, which resulted in a nationwide formula shortage.
Laurie J. Beyranevand, JD, a professor of law and director of the Center for Agriculture and Food Systems at Vermont Law and Graduate School in South Royalton, says it’s important to note that the DOJ has both a civil and criminal unit. “Last May, the civil unit of the DOJ filed a complaint and entered into a consent decree with Abbott Laboratories that enabled them to resume manufacturing of infant formula after having been previously enjoined from production,” she tells Food Quality & Safety. “The complaint alleged that Abbott manufactured adulterated powdered infant formula under insanitary conditions that failed to protect it from contamination from certain bacteria including Cronobakter sakazakii and Salmonella.”
Under the consent decree, the company was required to retain outside experts to bring the Sturgis, Mich., facility into compliance with the requirements under the Food, Drug, and Cosmetic Act and current good manufacturing practices.
This new investigation is a criminal investigation of the company, though the scope remains unclear. “Given the severity of the violations—including the fact that a whistleblower said the company knew about the contamination and falsified records to prevent FDA officials from identifying problems related to the company’s processes for monitoring the presence of bacteria in formula—in conjunction with the ongoing formula shortages, the DOJ may have determined civil penalties were not sufficient to address the issue,” Beyranevand says.
Abbott Laboratories says that it is cooperating fully with the investigation.