House members grilled an Abbott Nutrition executive about the company’s failure to address health and safety violations at a Michigan manufacturing plant that helped drive a national shortage of baby formula.
House Energy and Commerce Committee members probed executives at major formula makers Abbott Nutrition, Gerber, and Reckitt in a marathon round of questioning Wednesday over the industry’s response to the ongoing shortage. Members pressed Christopher Calamari, Abbott's senior vice president for U.S. Nutrition, particularly hard over the company’s failure to remedy health violations at Abbott’s Sturgis, Michigan, manufacturing plant before the February recall that shuttered the plant and exacerbated the shortage.
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“I have to be really clear about why we're here today: because Abbott Nutrition has consistently failed for years to implement basic safety procedures at Sturgis,” said Rep. Debbie Dingell (D-MI).
Abbott was placed under the microscope in Wednesday’s hearing, which started with testimony from Food and Drug Administration leadership. FDA Commissioner Robert Califf put forward a timeline of actions the agency took to investigate unsanitary conditions at the Sturgis plant that were outlined in a whistleblower report made public in April. In it, the former Abbott employee detailed lax hygiene practices, falsification of records to appear in compliance with health requirements, and obstruction of FDA officers’ investigation into serious problems related to the facility’s system for checking for bacteria contamination in formula.
The FDA’s January inspection of the Sturgis plant was a result of several reports of infants becoming severely ill after consuming contaminated powdered formula made there. It also followed the whistleblower report, which made it to some FDA staff in late October but did not get to senior staff until February “due to an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues,” according to the agency.
Calamari, who acknowledged that Abbott let the public down, said company leadership had not seen the whistleblower report until it was made public by Congress in April. He did not go into detail about conditions in the Sturgis facility but told members of the committee that he was “deeply sorry” for the role his company played in the shortage.
“You don’t owe [an apology] to this congress, you owe an apology to the parents of children who got sick and possibly a couple that have died and to all the families out there who are struggling and suffering because they cannot get the product you produce so much of,” said Rep. Jan Schakowsky (D-IL).
Calamari maintained that “we do not know these allegations to be true.” Still, the agency uncovered what Califf called “egregiously unsanitary conditions” in the Abbott facility during the January for-cause inspection. It resulted in a recall of many Abbott products and a temporary shutdown of production in Sturgis.
“Frankly, the inspection results were shocking,” Califf said. “Standing water, cracks in the key equipment that present the potential for bacterial contamination to persist, particularly in the presence of moisture. Leaks in the roof, a previous citation for inadequate handwashing, and current poor foot sanitation, bacteria growing from multiple sides, and many signs of a disappointing lack of attention to the culture of safety.”
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Abbott and the FDA entered into a legally binding agreement in which the agency will have complete oversight of the plant’s remediation of problems identified in the inspection. Details of the agreement have not been made publicly available, but it is meant to scale up production in a matter of weeks. Without the legally binding consent decree, Califf said, he would not have confidence that the plant would produce safe formula.