Last January, a severe baby formula shortage hit parents in the United States that resulted in a desperate scramble to find food for their infants.
The federal government pointed a finger at Abbott Laboratories, which was forced to shut down operations after it was suspected that formula was shipping from a Michigan plant that had been contaminated with a deadly bacteria.
The jury is still out on whether the deadly bacteria that killed three infants came from the Sturgis, Mich., plant or not. But a subsequent investigation of the plant by the FDA turned up numerous, shocking violations including standing water, damage to drying equipment, and defects in the seams of formula cans, among other problems at the Sturgis plant. The FDA shut the plant down and recalled the formula.
A whistleblower had claimed that Abbott was covering up massive problems at the plant and falsifying reports to the FDA. This led to a full-blown criminal investigation by the Justice Department.
Attorneys with the Justice Department’s consumer-protection branch are conducting the criminal investigation, the people said.
The branch, which has criminal as well as civil authority, was involved last year in a settlement with Abbott that allowed its Sturgis plant to resume operations after Food and Drug Administration inspectors found a potentially deadly bacteria there.
“The DOJ has informed us of its investigation, and we’re cooperating fully,” an Abbott spokesman said.
The company reopened the plant in June after extensive cleaning and modifications to the equipment.
So what is the Justice Department looking for?
“Ongoing inadequacies in manufacturing conditions and practices at Defendants’ facilities demonstrate that Defendants have been unwilling or unable to implement sustainable corrective actions to ensure the safety and quality of food manufactured for infants, a consumer group particularly vulnerable to foodborne pathogens,” the department said in the complaint.
Abbott isn’t the first food company to be the target of a criminal investigation. A deadly outbreak of listeria led to Blue Bell ice cream pleading guilty to two misdemeanors and a fine of $19 million. And the restaurant chain Chipotle was fined $25 million after food-borne illnesses struck more than 1,000 of their customers.
Abbott is still trying to ramp up to full production of all its product lines.
The DOJ investigation comes just a few weeks after Abbott and Ohio Gov. Mike DeWine announced the company’s plans to build a new $536 million manufacturing facility in the state to produce specialty and metabolic formulas for medically-vulnerable children and adults who were hardest hit by the shortages. Abbott has struggled to ramp up production of the special formulas at its Sturgis plant, and has recently pushed back the availability of a slate of metabolic formulas to April.
There really wasn’t much that Biden could do about Abbott’s self-inflicted wounds, but he tried anyway. He flew a few cases of formula from Germany to the United States — sort of a Berlin Airlift in reverse. It made no dent in the shortage of baby formula, but it certainly was a dramatic gesture.
The problem of shortages was a government-made problem. Regulations made any foreign competition very difficult — which was the idea when major domestic baby formula manufacturers lobbied for the change. Now we’re at the mercy of three or four companies that produce 90% of baby formula in the U.S.
That’s got to change, or the crisis will repeat itself the next time a problem occurs at one plant.
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