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Dr. The Abbott Nutrition factory in Robert Califf, Michigan, which closed in February and sparked a widespread baby food shortage crisis, had a leaking roof, puddles on the floor, and cracks in basic production equipment that allowed bacteria to enter and survive, Dr. Robert Califf, head of the Food and Drug Administration, told a House panel on Wednesday.
Sturgis detailed the “horribly unsanitary” conditions at the Michigan plant to lawmakers during a hearing, but also acknowledged that his agency was too slow to address issues at the plant.
“Frankly, the inspection results were shocking,” said Dr. Califf, to members of the House Energy and Trade Surveillance and Investigations Subcommittee. “We did not trust the integrity of the quality program at the facility,” he said, noting that the agency was working with Ministry of Justice officials to determine the steps it should take to turn the facility.
Abbott spokesman Jonathon Hamilton said that effort is expected to culminate in the factory reopening on June 4, with a formula expected to launch on June 20. Officials hope the new shipments will reach store shelves in six to eight weeks, but full production at the factory will take longer despite the restart.
Dr. Califf said Abbott replaced the leaky roof and floor at the facility.
Council members harshly questioned the commissioner and other agency officials at the hearing. They also sought answers from an Abbott executive about the facility’s troubled history and how the company would address the obvious shortfalls and shortages that have afflicted families across the country.
Christopher Calamari, senior vice president of Abbott Nutrition, offered little explanation for the conditions at the Michigan plant, but said he was “very, very sorry” about the famines. He said the company is coordinating 50 flights a week from its formula factory in Ireland to a dozen US airports to increase supply.
“We are committed to ensuring that this never happens again,” Kalamar said.
Alabama Republican Representative Gary Palmer pressed Mr. Calamari for details on why the company did not fix the problems at the factory before the FDA forced its hand.
“We prioritize security and compliance across our facilities,” Kalamar said. “And we’re committed to doing that and getting better out of this event.”
Mr. Palmer said he was not satisfied with this response.
Committee members disputed claims by the FDA and the Biden administration that it was difficult to recognize in real time the extent of the contamination and the consequent nationwide breakdown in the supply chain. The Abbott factory produced a quarter of the nation’s infant formula, including special formulas for people with special nutritional needs.
“The FDA had a life and death crisis ahead of them, but they failed to see the gravity of the situation,” said Washington Republican Representative Cathy McMorris Rodgers. “We need to address the urgent problem and at the same time make sure we take action so that this situation never happens again.”
Read More About Infant Formula Deficiency
The agency discovered a number of problems at the factory last fall. At the same time, reports of babies being hospitalized with a rare bacterium began to appear. Cronobacter sakazakii, which can be fatal to infants, was found in four infants who consumed plant formula, according to the Centers for Disease Control and Prevention.
Statements during the trial made it clear that it took months for the FDA to try to match the bacteria that made the first baby sick with the bacteria found in the plant later on.
The Cronobacter strains related to two of the babies did not match the bacterial samples found later on the plant, but Dr. Califf said the agency views these results as “inconclusive” because of the deficiencies in genome sequencing.
Diseases prompted the recall this year. The plant’s closure began on February 17 and exacerbated the intermittent famines during the peak of the pandemic. Empty shelves put parents in a difficult position, who traveled hundreds of miles to find baby food and sometimes improvised to feed hungry babies.
Dr. Califf also acknowledged several ways the FDA erred in addressing this issue: He said the follow-up audit in January should have started sooner, adding that the agency took too long to disseminate a tip-off report that came in October, but it succeeded. He won’t be able to reach senior officials until February.
Dr. “It was very slow and there were suboptimal decisions along the way,” Califf said.
He told lawmakers the agency did not receive an immediate notification when a formula plant found the deadly Cronobacter bacterium. The agency also does not have access to the supply chain information that each of the three main US baby food manufacturers has in-house.
This report An unidentified informant who said he worked at the Sturgis factory came up repeatedly during the trial. The whistleblower claimed that security personnel there “congratulated” the FDA for ignoring the issues after a 2019 review and not destroying enough of the product when it found Cronobacter in finished products. Mr Palmer said “it is very impressive to me” that senior agency officials did not see these allegations until February.
Washington Democratic Representative Kim Schrier said details in the report were “corruption” at the facility. Dr. Califf said he could neither confirm nor deny whether there would be criminal prosecution in the future.
Mr. Calamari stressed that the whistleblower’s allegations were unsubstantiated. “This is an open investigation,” he said. “And it continues.”
The report’s allegations resonated with panel members on both sides, including Republican Representative Larry Bucshon from Indiana, who described himself as a “private business man.”
“The culture of this facility seems to be an issue,” said Mr. Bucshon. “It seems to me that the company needs to do better with surveillance.”
Mr. Calamari claimed that Abbott has invested tens of millions of dollars in quality and maintenance, and praised the dedication of the workers at the 700,000-square-foot facility he visited last week.
“I saw team members there,” he said. “They have the power to speak and are passionate about what they do and make these products seem like they are for their own family.”
Several panel members called for tighter inspections of food safety and more frequent inspections of problem facilities.
Navigating A Deficiency Of Infant Formula In The U.S.
It’s a growing problem. A nationwide shortage infant formula – partially triggered by supply chain issues and worsened with a recall by baby food maker Abbott Nutrition – leaving parents confused and worried. Here are some ways to manage this uncertainty:
Ministry of Justice last week. consent decree announced He learned with Abbott about the conditions for reopening the Sturgis facility, and the company could face hefty fines if it doesn’t comply. In a complaint supporting the decree, authorities identified contamination with Cronobacter bacteria in finished baby powder formulas as long as 2019 and 2020.
Abbott officials were “unwilling or unsuccessful to implement sustainable corrective actions to ensure the safety and quality of food produced for infants”. complaint has been settled.
Cronobacter sakazakii bacteria thrive in dry conditions such as making powdered food. Only one state, Minnesota, requires doctors or laboratories to report cases of foodborne illness from bacteria to public health officials, who in turn are required to alert the CDC, The New York Times. reported.
Illinois Democratic Senator Tammy Duckworth urged the CDC to change protocols. “Our country’s inadequate reporting system results in critical data gaps that undermine our ability to understand the true extent of Cronobacter infections in infants.” letter Sent on Wednesday.
At the subcommittee hearing, Dr. Califf agreed that it was necessary to report cases involving the bacteria.
Last week, President Biden introduced the Defense Production Act to boost formula production and authorized the use of airplanes to speed up shipments of baby food from overseas to the United States. First military aircraft to carry 500,000 bottles of formula Arrived in Indianapolis from Europe on Sunday.
During the hearing, Xavier Becerra, secretary of Health and Human Services, tweeted out He said 60 tonnes of baby food had “just arrived on US soil”. He posted a photo of First Lady Jill Biden in front of the FedEx plane that was delivering an overseas shipment on Wednesday.
The FDA said last week that it has created a streamlined process for foreign baby food manufacturers to ship their products to the United States. On Tuesday, it announced that a company had approved its application. send two million boxes.
Mr Biden also enacted the signed law Expanding the types of formula available for purchase through the federal food aid program for women and infants cleared both chambers of Congress with few objections. A House-to-home emergency $28 million measure However, efforts to increase staff numbers for the agency stalled as some senators questioned whether the money could adequately make up for the shortfall.
“We don’t want anyone to be deprived of baby food or anything,” said Senator Richard Shelby of Alabama, the top Republican on the Senate Appropriations Committee. “Let’s see if we need it – the answer isn’t always money. The answer is good government and market forces.”
It is unclear what other legislative steps Congress will take. But as pleas from desperate parents seeking formulas flooded Capitol Hill, lawmakers both turned to Dr. They hastily scheduled sessions to question Califf and senior industry executives about the failures that had caused the famine.
Two more hearings are scheduled for this week with the Home Appropriations subcommittees meeting of a delegation of experts Wednesday and Dr. Califf set to appear In front of the Senate’s Health, Education, Work and Pensions Committee on Thursday.
Emily Cochrane contributed to this report.
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