Food Safety Concerns
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Could FDA Inspections Have Stopped Contaminated Baby Formula From Reaching Consumers? Errors by the FDA and the formula manufacturer may have contributed to infant fatalities and hospitalizations.
by Clara Johnson
April 21, 2022
In a significant move on February 17, baby formula producer Abbot announced a widespread recall of various powdered infant formulas made at its Sturgis, Michigan facility. This action was prompted by inspections from the Food and Drug Administration (FDA), which discovered five strains of Cronobacter, a hazardous bacterium linked to four hospitalizations and two infant deaths associated with the formula from that facility. In light of this tragedy, consumer advocates and health experts are scrutinizing the FDA’s inspection procedures and policies, particularly during the pandemic, which may have played a role in the unfortunate events.
An investigation by Politico uncovered a troubling detail: the first report of an ill infant surfaced back in September 2021, coinciding with the FDA’s first inspection of the plant since 2019. This initial inspection revealed several minor issues, yet there was no indication of bacterial contamination in the infant formulas – raising doubts about the thoroughness of the inspection. By the time the FDA launched another inspection in late January, two infant deaths had already occurred. Why was there a four-month interval between inspections despite reports of illness? Additionally, how did the plant go two years without an inspection when annual checks are standard protocol?
The absence of the 2020 inspection can likely be attributed to the pandemic when the FDA limited inspections to those deemed “mission critical,” as highlighted by Politico. It remains unclear why a facility that produces infant formula, essential for a vulnerable population, was not classified as ‘critical.’ According to agency representatives, such decisions were made on a case-by-case basis.
Some findings from the FDA’s more recent inspection were alarming, such as evidence that Abbot had detected Cronobacter in its own internal inspections in September 2019 and June 2020, resulting in the destruction of affected products. It is also uncertain whether FDA inspectors were informed about the first reported Cronobacter case during their September visit, a detail that could have influenced their assessment.
Dr. Lisa Grant, a regulatory affairs expert, remarked, “This situation underscores the need for more stringent inspections of baby formula. Clearly, the FDA overlooked crucial issues during their last visit.” She further questioned, “What else might they have missed if they failed to catch these significant problems?”
An FDA spokesperson stated that the agency plans to review the incident “once the immediate public health risk is minimized.” Microbiologist Tom Fisher, who operates a food safety blog, emphasized that both the manufacturer and the FDA share responsibility. “In the end, it’s the company’s duty to keep its equipment and safety protocols in check, while the FDA must ensure compliance,” he noted. “There have been failures on all sides.”
We can only hope that these inquiries will prompt the FDA, Abbot, and other infant formula manufacturers to enhance their protocols to prevent future contamination. The safety of children is on the line. For information on whether your purchased formula is part of the recall, check out this resource or visit the CDC for more information on pregnancy and home insemination.
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Summary:
The FDA is facing scrutiny after a major recall of baby formula by Abbot, linked to infant deaths and hospitalizations. Questions are being raised about the adequacy of the FDA’s inspection processes, particularly regarding the timeline and thoroughness of inspections during the pandemic. Experts are calling for stricter oversight and accountability to ensure the safety of infant formulas.
Keyphrase: FDA baby formula recall
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