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Product may be contaminated with Listeria monocytogenes.
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Failed Impurities/Degradation Specifications