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Consumer advocates and health professionals are scrutinizing the FDA’s inspection protocols, particularly during the pandemic, which may have contributed to these tragic outcomes. An investigation by Politico revealed a troubling timeline: the first report of an ill infant was logged in September 2021, coinciding with the FDA’s first inspection of the plant since 2019. Although this inspection identified some minor issues, it failed to detect any bacterial contamination in the formulas. This raises concerns about the thoroughness of the inspection process.
Compounding the issue is the fact that the plant had gone without an inspection for two years, a stark contrast to the typical annual inspection cycle. During the pandemic, the FDA had restricted inspections to those deemed “mission critical,” but it remains unclear why an infant formula plant, essential for the nutrition of vulnerable infants, was not classified as such.
Further investigations revealed that Abbot had previously detected cronobacter in its own internal checks in September 2019 and June 2020, leading to product destruction. Questions linger about whether FDA inspectors were informed about the initial illness report during their September visit—a detail that could have influenced their findings. Sara Tanner, a regulatory affairs expert, emphasized the need for more stringent inspections, stating, “The most recent inspection caught numerous issues that were overlooked previously.”
An FDA representative indicated plans for a review of the incident once the immediate health risks have been addressed. Additionally, microbiologist Phyllis Dunn noted that the failures lie with both the manufacturer and the FDA, urging that both parties must be held accountable for ensuring food safety.
It is hoped that these investigations will compel the FDA, Abbot, and other infant formula manufacturers to enhance their protocols to prevent future contamination tragedies. The stakes are high when it comes to the safety of infants. For those wanting to check if their purchased formula is part of the recall, visit www.similacrecall.com.
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Summary:
The FDA is facing intense scrutiny following a massive recall by Abbot of its baby formula after multiple infant illnesses and two deaths linked to cronobacter contamination. Investigations reveal serious lapses in inspection procedures and oversight, particularly during the pandemic. Experts are advocating for more rigorous inspection protocols to safeguard vulnerable populations.