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Chapter 7 Recall Procedures
This chapter contains the following sections:
7-1 - PURPOSE
7-2 - BACKGROUND
7-3 - SUMMARY OF FDA RESPONSIBILITIES AND PROCEDURES
7-3-1 - Responsibilities Of The Office Of Enforcement/Division Of Compliance Operations And Management (HFC-210)
7-3-2 - Responsibilities And Procedures – Office Of Enforcement/Division Of Compliance Policy (HFC-230)
7-4 - RECALL ENTERPRISE SYSTEM
7-5 - INITIATION OF A RECALL
7-5-1 - Firm Initiated Recalls
7-5-2 - FDA Requested Recall
7-5-3 - FDA Ordered Recalls
7-6 - RECALL CLASSIFICATION AND STRATEGY
7-6-1 - Health Hazard Evaluation
7-6-2 - Classification Process
7-6-3 - Classification Notification And Routing
7-6-4 - Recall Strategy
7-7 - NOTIFICATIONS AND PUBLIC WARNING
7-7-1 - Reports And Reporting Procedures
7-7-2 - Notification Of Other Governments And Agencies
7-7-3 - Public Warning
7-8 - MONITORING AND AUDITING RECALL EFFECTIVENESS
7-8-1 - Recall Effectiveness
7-8-2 - Managing FDA’s Audit Program
7-9 - RECALL TERMINATION
7-10 - ATTACHMENTS AND EXHIBITS
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