FDA: Conditions at baby formula plant shocking
Agency chief also acknowledges to House panel they were slow to respond
The Abbott Nutrition plant in Michigan that was shut down in February, sparking a widespread baby formula shortage crisis, had a leaking roof, water pooled on the floor and cracks in key production equipment that allowed bacteria to get in and persist, Dr. Robert Califf, the head of the Food and Drug Administration, told a House panel Wednesday.
He detailed “egregiously unsanitary” conditions in the Sturgis, Michigan, plant to lawmakers during a hearing, but he also acknowledged his agency was too slow in response.
“Frankly, the inspection results were shocking,” Califf said. “We had no confidence in the integrity of the quality program at the facility,” noting the agency worked with Justice Department officials to dictate steps the company needed to take to turn the facility around.
That effort is expected to result in the facility reopening June4, Jonathon Hamilton, an Abbott spokesperson, said, with some formula expected to begin rolling out June 20. Officials hope new shipments will reach store shelves within six to eight weeks, although resumption of full production at the plant will take longer.
Abbott has replaced the leaking roof at the plant as well as the floor, Califf said.
Members of the House Energy and Commerce Subcommittee on Oversight and Investigations pushed back against the agency’s assertions that it was difficult to recognize in real time the extent of the contamination and the resulting nationwide breakdown in supplies. The Abbott plant had produced one-quarter of the nation’s infant formula, including formulas tailored for people with specialized nutritional needs.
“There was a life-and-death crisis in front of the FDA, but they failed to see the severity of the situations,” said Rep. Cathy McMorris Rodgers, R-Wash. “We must solve the immediate issue and also ensure that we are taking action so this situation never happens again.”
In opening remarks, Christopher Calamari, an Abbott Nutrition senior vice president, said little about conditions at the Michigan factory but said he was “deeply, deeply sorry” about the shortages. He said the company was coordinating 50 flights per week from its formula plant in Ireland to a dozen U.S. airports to help bolster supplies.
“We are committed to ensuring that this never happens again,” Calamari said, noting that the company will add redundancy to its operations.
He later said the company is verifying that every step is in place to ensure the quality checks are working throughout the 700,000-squarefoot facility in a sustainable way.
The agency discovered a battery of problems at the plant in the fall. At the same time, reports began emerging of babies who had been hospitalized with a rare bacteria. Cronobacter sakazakii, which can be deadly to infants, was found in four babies who had consumed formula from the plant, according to the Centers for Disease Control and Prevention.
Testimony during the hearing made it clear that the FDA took months to try to match the bacteria that sickened the first baby to bacteria that was later found throughout the plant.
Cronobacter strains related to two of the babies did not match samples of the bacteria later taken at the plant, although Califf said the agency considers those results “inconclusive” given shortcomings with genome sequencing.
The illnesses set the recall in motion. The plant shutdown began Feb. 17 and led to shortages that have left parents struggling, driving hundreds of miles to find baby formula and, at times, improvising to feed hungry infants.