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The companies have 15 working days from the receipt of the letters to give the FDA a detailed written breakdown of their corrective actions
Majack, R
Hsieh MJ, Lee CH, Chueh HY, et al
If the cause of B12 deficiency is unclear, testing for intrinsic factor antibodies (and sometimes parietal cell antibodies) can help diagnose pernicious anaemia, an autoimmune condition affecting B12 absorption
In the stomach, hypochlorhydria associated with atrophic gastritis interferes with vitamin B 12 release from the food and causes intestinal bacterial overgrowth to compete for vitamin B 12 uptake, resulting in a decline in vitamin B 12 in the body