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). Based on the attached readings, 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?
