FDA Chief Had This to Say About Abbott’s Baby Formula Plant’s Conditions

According to Food and Drug Administration Commissioner Robert Califf, inspections found “shocking” conditions at Abbott’s infant formula plant in Michigan.

The plant had ‘egregiously unsanitary’ conditions, the FDA chief said in testimony to Congress.

Califf said Abbott CEO Robert Ford told him the plant could resume production in early June, but the facility has to implement hundreds of steps before it can reopen to ensure food safety.

According to Califf, the investigation couldn’t conclude that unsanitary conditions led to four infants falling ill, two of whom died, but he called the confluence of events “highly unusual.”

The Commissioner described bacteria growing from multiple sites in the facility, cracks in key equipment, leaks from the roof, standing water and a previous citation for inadequate handwashing.

“Frankly, the inspection results were shocking,” Califf told House lawmakers on the Oversight and Investigations subcommittee. “This is so far removed from my previous experience with the company that I am concerned.”

Abbott closed its Sturgis, Mich., plant and recalled multiple baby formula products in February, after the FDA found five different strains of Cronobacter at the facility.

Four infants who consumed powdered formula from the Abbott plant fell ill and were hospitalized with Cronobacter infections and two of them died.
Califf said the FDA and the Centers for Disease Control and Prevention’s investigation couldn’t conclude that the insanitary conditions at the plant caused the illness. None of the Cronobacter strains at the Sturgis plant matched two clinical samples from the ill infants, according to the FDA.

“Abbott’s enormous market share left it with a responsibility for producing safe infant formula that wasn’t met,” Califf said. “We will do everything in our power to work with Abbot to make this happen as quickly and safely as possible but this timing is in Abbott’s control.”

“This is a war mentality. It is a crisis. We are fully aware of it. Families should not be searching for formula, but they have to do it now until we fill in,” Califf said.

Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.