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CGMP Deviations
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Super-Potent Drug: Out of specification potency results were obtained.
Lack of Assurance of Sterility
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.