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The Food and Drug Administration (FDA) has acknowledged that its response to the infant formula shortage is hampered by outdated technology and delays.
In a 10-page report, the agency said the technology that supports systems that allow the public and other stakeholders to submit product safety and quality complaints, adverse event reports and product manufacturing issues is obsolete.
Additionally, “inadequate processes and a lack of clarity” related to whistleblower complaints may have delayed the FDA’s response to those complaints.
A company whistleblower had tried to notify the FDA about problems at Abbott Nutrition’s Sturgis, Michigan facility in the fall of 2021, but government inspectors only investigated the complaints. months later.
The agency previously told Congress that agency officials were not notified of the complaint until February due to mail delays and a failure to escalate the Abbott employee’s allegations. .
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The administration also found that some samples taken at the Michigan plant were delayed in transit by third-party delivery companies.
The FDA said it had to postpone its initial inspection of Abbott’s plant due to COVID-19 cases among company personnel.
Of a total of 15 findings, the FDA said the emergency response lacked clarity of roles between programmatic and incident command standard operating procedures; the agency needed effective mechanisms to quickly engage with regulatory and public health partners to avoid confusion; its investigators have received limited training specific to infant formula; funding limitations had stalled the food program’s growth; record keeping practices were outdated and the FDA lacked the capacity to manage supply chain issues.
Some of the findings were related to the nature of the problem, with the report noting that consumer education regarding the safe handling and preparation of infant formula is limited and that the incident required “an unusual level of involvement from management in the agency to assess and weigh the risks associated with product contamination against the risks of unavailability of essential products due to shortages.
Cronobacter is not a nationally reportable disease and gaps in understanding the contamination would have hampered the FDA’s response.
The FDA said conditions at Abbott Nutrition facilities “are not consistent with a strong culture of food safety.”
The FDA report was the result of dozens of interviews with personnel and executives directly involved in the events.
The shortage of domestic preparations was triggered mainly by the closure of the production plant in Michigan.
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The factory was shut down after the cronobacter pathogen was detected in the supply and led to at least four childhood illnesses, including two deaths.
An investigation into the links between the diseases and the formula is underway.
Abbott previously told FOX Business in a statement that “there is no causal relationship between Abbott’s products and the reported deaths.”
“Abbott performs microbiological testing on products prior to distribution and no Abbott formula distributed to consumers has tested positive for Cronobacter sakazakii or Salmonella,” the company said. “All retained products tested by Abbott and the FDA during the facility inspection have tested negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility. »
The shortage has forced the United States to airlift millions of pounds of powdered formula from overseas.
Since then, US formula supplies have improved and the factory has started producing formula.
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The Associated Press contributed to this report.