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Abbott formula plant had ‘egregiously unsanitary’ conditions, FDA chief says in scathing testimony


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The head of the Food and Drug Administration and executives from the infant formula industry are set to answer questions from House lawmakers Wednesday about the nationwide shortage that has left parents struggling to find food for their infants.

The House Oversight and Investigations subcommittee hearing will begin at 11 a.m. Lawmakers will question FDA Commissioner Robert Califf, FDA food policy chief Frank Yiannis, and the director of the FDA’s food safety center Susan Mayne during the first portion of the hearing.

The FDA has come under scrutiny from lawmakers for not acting quickly enough to inspect Abbott Nutrition’s infant formula plant in Sturgis, Mich., after a whistleblower warned the agency in October about food safety violations at the plant. The FDA didn’t initiate inspections of the plant until late January, ultimately finding five different strains of Cronobacter – a bacteria that can cause a dangerous blood infection – at the facility.

Four infants who consumed powdered formula from the Abbott plant fell ill and were hospitalized with Cronobacter infections, two of whom died. The FDA, in testimony released ahead of the hearing, said it does not have definitive evidence proving proving the bacteria found at the plant caused the infant illnesses. None of the Cronobacter strains at the Sturgis plant matched two clinical samples from the ill infants, according to the FDA. However, the agency said Cronobacter found at manufacturing plants is considered one of the most likely sources of contaminated infant formula.

Abbott shut down the plant and initiated a voluntary of recall of several products in February, contributing to an infant formula shortage that has left store shelves empty in many parts of the country. Four manufacturers – Abbott, Mead Johnson Nutrition, Nestle USA and Perrigo – control 90% of the domestic infant formula market in the U.S.

House lawmakers will also question Abbott executive Christopher Calamari, Gerber Vice President Scott Fritz, and Reckitt Senior Vice President Robert Cleveland. Nestle owns Gerber and Mead Johnson merged with Reckitt in 2017.

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