Ann: USA FDA discretion to import Bubs Infant Formula, page-72

FDA Commissioner says unsanitary conditions at Abbott Labs Michigan baby formula factory were “shocking”
Kevin Reed
26 May 2022

On Wednesday, the head of the Food and Drug Administration (FDA) told a House of Representatives panel that the agency’s inspection of Abbott Nutrition’s Sturgis, Michigan facility, the largest baby formula factory in the US, found conditions that were “shocking” and “egregiously unsanitary.”


Food and Drug Administration Commissioner Robert Califf testifies during a Senate Committee on Health, Education, Labor and Pensions hearing on the nationwide baby formula shortage on Capitol Hill in Washington, Thursday, May 26, 2022. (AP Photo/Jose Luis Magana)
During sworn testimony before the House Subcommittee on Oversight and Investigations of the Energy and Commerce Committee, FDA Commissioner Dr. Robert Califf said, “We had no confidence in integrity of the quality program at the facility,” that produced 25 percent of US baby formula before it was shut down in February of this year for being contaminated with bacteria as well as other violations.

Califf described bacteria growing in multiple sites within the complex, cracks in key equipment, leaks in the roof, standing water and inadequate handwashing by staff. The FDA found five different strains of Cronobacter, bacteria that can cause dangerous blood infections, at the Michigan facility. Beginning in September 2021, four infants who consumed the powdered formula produced by the Abbott factory became sick and were hospitalized with Cronobacter infections. Two of these babies died.