The Department of Justice’s Consumer Protection Division has launched a criminal investigation into the actions of Abbott Laboratories, one of the nation’s largest formula makers, at the center of a contamination scandal and ongoing nationwide shortage.
The investigation’s existence was first reported by The Wall Street Journal. The DOJ has not commented, but an Abbott spokesperson said the Department of Justice has been notified of the investigation and the company is “cooperating fully.”
Federal regulators last year found numerous violations and “grossly unsanitary” conditions at Abbott’s plant in Sturgis, Michigan, the nation’s largest milk powder factory. Reports had been received that at least four babies who had been breastfed had become ill with dangerous bacterial infections. Cronobacter sakazakii, It has also been detected in plants. Two of the infants died.
The Food and Drug Administration had also received whistleblower complaints alleging safety breaches, falsification of records, and cover-ups at the facility. But it took months for the complaint to reach his FDA officials, during which time one of his infants died and others fell ill. The FDA’s clumsy complaint handling provoked a backlash from lawmakers and an external FDA review.
Abbott, on the other hand, has denied formula is the cause of infant illness and death. C. sakazaki The strain found at the Sturgis facility did not match genetically to the strain found in an open formula container in one of the sick infant’s homes. (There is no genetic data on the strain infecting her other two infants.) Food safety experts at the FDA dismissed Abbott’s claims. C. sakazaki Found in plants, the facility’s sampling could have easily missed other strains. Testing tiny prescription batches totaling hundreds of thousands of pounds often misses low levels of contamination.
“unwilling or unable to”
An FDA investigation closed the Sturgis facility last February, exacerbating a nationwide prescription shortage. Parents were left facing the bare shelves of stores as they desperately searched for food for their children. Federal officials have abandoned regulations and tariffs, flew prescriptions from abroad, and rushed to increase supplies. Enfamil maker Reckitt Benckiser reported in December that he expected the supply shortage to last until spring.
To safely return the Sturgis plant to operations, Abbott signed a legal agreement with the FDA last May, called a consent decree, outlining the strict steps Abbott must take to safely reopen the facility. .
In an accompanying complaint, the Department of Justice laid out a series of violations and failures discovered at the Sturgis facility. C. sakazaki It was on the premises and had previously been warned by the FDA.
“The continued deficiencies in manufacturing conditions and practices at Defendant’s facilities have led Defendants to ensure the safety and quality of food manufactured for infants, a consumer group that is particularly vulnerable to foodborne pathogens. of unwillingness or inability to implement sustainable corrective actions,” the ministry wrote. .
The Wall Street Journal says the department has successfully prosecuted other food companies and their executives for putting tainted food on the market. paid $19 million and pleaded guilty to transporting contaminated ice cream. Listeria An outbreak that killed three people. In 2015, Stewart Parnell, former owner of Peanuts Corporation of America, salmonella Nine people died and more than 700 became ill. He was sentenced to 28 years in prison.
