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Pernicious anaemia (an autoimmune condition affecting B12 absorption) is a common cause of B12 deficiency that requires specific testing for anti-intrinsic factor antibodies

The Core Issue Was Trust in the Quality System The Warning Letter highlights one message repeatedly: FDA no longer trusted the data generated by the facility

Accordingly, it has been agreed that developing an evidence-based consensus statement outlining novel and effective intervention approaches to address the healthcare needs of individuals and communities is crucial for providing a scientific basis to promote an individual's optimal health status and improve the public health of nations worldwide

Li et al., 2021)