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CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
The firm was notified by the FDA that they failed to included a shellfish allergen on their ingredient panel.
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
The firm was notified that the product contains undeclared soy.
They were notified by their supplier that the product may be contaminated with foreign material.