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Dereliction Of Responsibility By FDA Over Inspection of Baby Formula Plants


It was recently disclosed that during 2020, U.S. FDA inspectors failed to visit any of the major manufacturers of baby formula.  Their justification was based on restrictions associated with COVID.


The Abbott Nutrition  plant in Sturgis, MI was not reviewed for over two years.  When inspected, a number of deficiencies were observed in both structure and operations.  Notwithstanding this situation, the plant was not reinspected until after outbreaks of Cronobacter sakazaki infection were diagnosed and attributed to contaminated formula produced by the facility.  The FDA was tardy in responding to a detailed whistleblower complaint regarding deficiencies in the Sturgis plant and the activities of management to obstruct FDA inspectors.  Following a detailed evaluation of the plant, a recall was issued in February 2022 and the plant was closed for decontamination and retraining of personnel.  This action resulted in a widespread shortage of formula, given that the plant was responsible for a significant proportion of baby formula manufactured in the U.S.


Following Congressional involvement, the Food and Drug Administration is now obliged to inspect all plants manufacturing infant formula at six-month intervals.


Deficiencies in both the organization and activities of the FDA as disclosed in hearings should result in radical changes.  Establishing a separate food safety agency would be justified given the appalling record of insensitivity and non-awareness of problems leading to this and previous foodborne infections.  The fact that food safety is fragmented among various federal departments, including the USDA for red meat and poultry and the FDA for virtually all other foods including imported products, is an obvious organizational defect and should be rectified.