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The Food and Drug Administration (FDA) has acknowledged that its response to the shortage of infant formula has been hampered by outdated technology and delays.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 interested parties to file product safety and quality complaints, adverse event reports, and product manufacturing issues is obsolete.
Additionally, “inadequate procedures and lack of clarity” regarding whistleblower complaints may have delayed the FDA’s response to such complaints.
In the fall of 2021, a company whistleblower tried to alert the FDA of problems at the Abbott Nutrition facility in Sturgis, Michigan, but government inspectors did not investigate the complaints until months later.
The agency previously told Congress that agency officials were unaware of the complaint until February due to mail delays and the lack of escalation of employee Abbott’s allegations.
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The administration also found that some samples taken from the Michigan plant had been delayed in transit by third-party delivery companies.
The FDA said it needed to reschedule its initial inspection of Abbott plans due to cases of COVID-19 among company staff.
In a total of 15 results, the FDA said emergency response lacked clarity of roles between programmatic command and incident standard operating procedures; the agency needed effective mechanisms to engage rapidly with regulatory and public health partners to avoid confusion; its investigators received limited specific training on infant formula; funding limits had blocked the growth of the food program; record keeping practices were out of date and the FDA does not have the capacity to manage supply chain problems.
Some findings were related to the nature of the problem, with the report showing that consumer education about the safe handling and preparation of infant formula is limited and the incident required “an unusual level of involvement from the leadership of the infant. agency to assess and weigh the risks associated with potential product contamination against the risk of essential products not being available due to a shortage. “
Cronobacter is not a nationally reportable disease and gaps in understanding of contamination would have hindered the 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 leadership directly involved in the events.
The national formula shortage was mainly triggered by the Michigan manufacturing plant shutdown.
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The plant was closed after the pathogen cronobacter was detected in the supply and caused at least four childhood illnesses, including two deaths.
An investigation into the links between the diseases and the formula is ongoing.
Abbott previously told FOX Business in a statement that “there is no causal relationship between Abbott products and reported deaths.”
“Abbott conducts microbiological testing on products prior to distribution and no Abbott formulas distributed to consumers have tested positive for Cronobacter sakazakii or Salmonella,” the company said. “All of the retained product tested by Abbott and the FDA during the facility inspection was negative for Cronobacter sakazakii and / or Salmonella. No Salmonella was found in the Sturgis facility.”
The shortage has forced the United States to fly millions of pounds of formula powder from overseas.
Since then, U.S. infant formula stocks have improved and the plant has begun to produce infant formula.
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The Associated Press contributed to this report.