TRIGGERING OF INSPECTIONS
There are two types of events that trigger inspection: categories that will regularly prompt an inspection request,
and categories in which the district office may elect to perform an inspection at their discretion for elements of
applications — filed or otherwise.
The following categories will regularly prompt a pre-approval or cGMP:
1. New molecular entities (includes finished drug product and the active pharmaceutical ingredient)
2. Priority NDAs
3. First application filed by an applicant
4. For-Cause inspection
5. For original applications, if the current cGMP status is unacceptable or greater than 2 years
6. For certain preapproval supplements, such as site change or major construction, if the cGMP status is unacceptable
7. Treatment IND inspections (information is available to CDER indicating that an inspection of a clinical supplies manufacturer is warranted to protect the health of patients)
