World of Compliance Module

International Compliance

In the area of international compliance, OC:

• Assigns surveillance, pre-approval and compliance inspections for scheduling
• Provides guidance to the inspection cadre
• Evaluates completed inspection reports
• Advises CDER review divisions about acceptable or non-acceptable classification of firms, and completes appropriate regulatory or administrative action
• Generates assignments for-cause, pre-approval and post approval; forwards assignments for investigations
• Reviews and evaluates all cases (No Action Indicated (NAI), Voluntary Action Indicated (VAI), Official Action Indicated (OAI), and makes final recommendations to ensure that firms are in compliance with cGMP
• Takes action: withhold (warning or untitled letters) and/or import alert
• Respond to general inquiries submitted by consumers
• Participates in facility review meetings with the industry
• Provides guidance and/or training to center(s), Agency, field and industry
• Performs international inspections