World of Compliance Module

Types of Inspections and Classification of Findings

The two types of FDA inspections are:

• Routine (also known as data audits) that are in support of NDAs
• Directed that generally respond to complaints or reports of serious problems

Regulated parties are required to report serious problems or complaints to FDA.

FDA receives internal complaints, complaints from subjects and staff members involved in research, and anonymous complaints.

For all complaints, OC determines when it is appropriate to follow up with an inspection. If an ORA investigation reveals regulatory violations, it will be outlined in the report.