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CGMP Deviations: Presence of NDMA impurity detected in product.
The firm discovered that the allergen soy was not declared in the ingredient statement or allergen declaration.
The product ingredient statement does not list walnuts in the product.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Elevated histamine levels.