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It attributed Indias cost advantage to high-production capacity plants, processimprovements, economies of scale, and backward integration in manufacturing. It noted that US law requires complete manufacturing addresses to be printed on generic drug packaging and listed in the FDAs Orange Book database.
Corrective and preventive actions are identified and implemented as the outcome of investigations such as deviations, product complaints, internal audit observations, risk assessments, stability failure, or other process or system-related non-conformances. The entire unused packaging lot which was quarantined was returned to the supplier.
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