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 preapproval or cGMP  

New molecular entities (includes finished drug product and the active pharmaceutical ingredient) 

For original applications, if the current cGMP status is unacceptable or greater than 2 years 

For certain preapproval supplements, such as site change or major construction, if the cGMP status is unacceptable 

---