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During an inspection of New Drug Biologics, the FDA inspector observed multiple problems with documentation and quality oversight that are a violation of current good manufacturing practices (cGMPs). what is the process for notifying New Drug Biologics of these observations? How is New Drug Biologics able to respond after they have been notified of the observations?
If I were a competitor of New Drug Biologics, would I be able to find out what the FDA observed during the inspection? If so, how?
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