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Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture…
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture…
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture…
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture…
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the…
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.