The FDA's limited mandate and resources prevent them from managing 'supply chain issues and shortages of critical food products,' the review said.
at the heart of Abbott's massive shutdown, Cronobacter sakazakii, is "poorly understood" and lacks thorough federal oversight -- and that those "scientific gaps" in understanding Cronobacter "hindered the FDA's response throughout the incident."
Abbott's shutdown ricocheted across the country, exacerbating the supply shortage and forcing families to scramble for alternatives in the hyper-concentrated formula market.the response was "too slow," But this report contains several new details about repeated fumbles in the response, including crucial delivery system errors and a need for better staff communication at the FDA.
The review adds that the agency is "collecting an inventory of every entry point for consumers, whistleblowers, other government agencies, clinicians, and other members of the public to facilitate notification to the FDA of their concerns about product safety and quality," which will help "streamline" safety concerns to "rapidly assess emerging safety signals."
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