FDA Chief Testifies About Abbott Labs Recall, Unsanitary Conditions

NORTH CHICAGO, IL — The commissioner of the U.S. Food and Drug Administration outlined "egregiously unsanitary" conditions at the Abbott Laboratories baby formula manufacturing facility in Sturgis, Michigan, that was shuttered earlier this year amid an investigation into bacterial contamination.

Dr. Robert Califf testified Wednesday before the House Commerce Oversight and Investigations subcommittee in Washington, D.C., that his agency had been sent a whistleblower report about conditions at the plant in October 2021 but failed to heed it.

The food safety regulators were due to inspect the facility on Dec. 30, but due to an outbreak of COVID-19 at the plant, the FDA inspection did not take place until Jan. 31, according to the Associated Press.

The results of the inspection were "shocking," Califf said. Inspectors found standing water, a leaking roof, cracks in equipment that could lead to bacterial contamination and Cronobacter sakazakii bacteria growing in multiple locations, leading to the plant being shut down and a recall of formula produced there.

The recall and shutdown has contributed to a nationwide shortage of baby formula.

---

Abbott has announced plans to reopen the facility on June 4 following a federal civil complaint and consent decree with the Justice Department.

Califf said the FDA was unable to determine one way or another whether bacteria from the plant led to the four hospitalizations and two deaths among infants who had consumed Abbott's powdered formula.

Related: Nancy Pelosi Says Indictment May Be Needed Over Baby Formula Shortage

Asked about the possibility of criminal charges being filed against Abbott or its employees, Califf said he was unable to “either confirm or refute” whether there will be "criminal proceedings" resulting from operations at the Sturgis facility, Crain's Chicago Business reported.

Christopher Calamari, vice president of the North Chicago-based firm, apologized to consumers for the shortage, although he "repeatedly sidestepped" queries from lawmakers about whether Abbott had disciplined or fired any employees at the Sturgis plant, according to the Associated Press.

Watch FDA Commissioner Dr. Robert Califf's full May 25 testimony before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce: