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The Food and Drug Administration (FDA) has admitted that its response to the infant formula shortage is being hampered by outdated technology and delays.
In the 10-page report, the agency identified technology supporting systems that allow the public and other stakeholders to submit product safety and quality complaints, reports of adverse events, and concerns about product manufacturing. says it’s outdated.
Additionally, “inadequate processes and lack of clarity” associated with whistleblower complaints may have slowed the FDA’s response to those complaints.
A corporate whistleblower tried to alert the FDA in the fall of 2021 about problems at the Abbott Nutrition facility in Sturgis, Michigan, but government inspectors didn’t investigate the complaint until months later. did.
The agency previously told Congress that agency officials didn’t learn about the complaint until February because it failed to escalate the mail delay and the Abbott employee’s claims.
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The administration also found that some of the samples taken from the Michigan plant had been delayed in transit by a third-party shipping company.
The FDA said it had to reschedule the first inspection of the Abbott factory due to an outbreak of COVID-19 among company staff.
In its 15 total findings, FDA said emergency response clearly lacked a role between programs and incident command standard operating procedures. To avoid confusion, the agency needed an effective mechanism to quickly liaise with regulators and public health partners. The researcher received limited training specifically in infant formula. Food program growth was stagnant due to funding constraints. Record-keeping practices are outdated and the FDA lacks the ability to manage supply chain issues.
Some of the findings are related to the nature of the problem, with the report highlighting limited consumer education on safe handling and preparation of infant formula, suggesting that the incident had “potential It required an extraordinary level of agency leadership involvement to assess and weigh the risks associated with potential impacts.” Contamination of products to the risk that essential products will not be available due to shortages. “
Cronobacter is not a nationally reportable disease, and gaps in understanding the contamination reportedly hampered FDA’s response.
The FDA said the conditions observed at the Abbott Nutrition facility were “not consistent with a strong food safety culture.”
The FDA report was the result of dozens of interviews with staff and leaders directly involved in the event.
The national formula shortage was primarily caused by the closure of the Michigan production plant.
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The factory was shut down after the Cronobacter pathogen was detected in its supplies, leading to the illness of at least four infants, including two deaths.
Research into the relationship between disease and formula is ongoing.
Abbott previously told FOX Business that there was “no causal relationship between Abbott’s products and the reported deaths.”
“Abbott performs microbiological testing of its products prior to distribution, and none of the Abbott formulas distributed to consumers tested positive for Cronobacter sakazakii or Salmonella,” the company said. “All retained products tested by Abbott and the FDA during facility inspections were found to be negative for Chronobacter his Sakazaki and/or Salmonella. Salmonella was not detected at the Sturgis facility. did not.”
The shortage has forced the United States to fly millions of pounds of powdered formula from abroad.
Since then, U.S. infant formula inventories have improved, and factories have started producing infant formula.
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The Associated Press contributed to this report.