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Investigations Operations Manual
Foreword
Ch 1 Administration
Ch 2 Regulatory
Ch 3 Federal-State Cooperation
Ch 4 Sampling
Sample Schedules
Ch 5 Establishment Inspection
Ch 6 Imports
Ch 7 Recall Activities
Ch 8 Investigations
Exhibits
Appendix
ORA Directory
Change Log
Search
Inspection References
Investigations Operations Manual 2008
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Contents
7.1 - RECALLS
7.1.1 - DEFINITIONS
7.1.1.1 - Recall
7.1.1.2 - Recall Classification
7.1.1.2.1 - Class I Recall
7.1.1.2.2 - Class II Recall
7.1.1.2.3 - Class III Recall
7.1.1.3 - Recall Type
7.1.1.4 - Recall Strategy
7.1.1.5 - Depth of Recall
7.1.1.6 - Recall Number
7.1.1.7 - Medical Device Notification Order
7.1.1.8 - Medical Device Notification
7.1.1.9 - Medical Device Safety Alert
7.2 - RECALL NOTIFICATION / INSPECTION
7.2.1 - INSPECTION PROCEDURES
7.2.1.1 - Recall Decision Follow-up
7.2.2 - FOOD RECALLS
7.2.2.1 - Interstate Milk Shippers
7.2.3 - MEDICAL DEVICE RECALLS
7.2.3.1 - Problem Identification
7.2.3.2 - Corrective Action
7.2.3.3 - Complaint and Medical Device Reporting (MDR) Reporting
7.2.4 - DRUG RECALLS
7.2.4.1 - Recalls of Human Drug Products
7.2.4.2 - Recalls of Veterinary Drug Products
7.2.5 - Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) for Implantation, Transplantation, Infusion, or Transfer
7.2.6 - SAMPLE COLLECTION
7.2.7 - RECALL ALERT
7.2.8 - RECOMMENDATION FOR RECALL NUMBER
7.2.8.1 - Product
7.2.8.2 - Code
7.2.8.3 - Recalling Firm/Manufacturer
7.2.8.4 - Reason for Recall Recommendation
7.2.8.5 - Volume of Product In Commerce
7.2.8.6 - Distribution Pattern
7.2.8.7 - Firm's Recall Strategy
7.2.8.8 - Firm Official
7.2.8.9 - District Audit Program
7.2.8.10 - Recommending Official
7.3 - MONITORING RECALLS
7.3.1 - INSPECTIONS TO MONITOR RECALL PROGRESS
7.3.2 - FDA RECALL AUDIT CHECKS
7.3.2.1 - Definition
7.3.2.2 - Level of Audit Checks
7.3.2.3 - Sub-Account Checks
7.3.2.4 - Conducting the Check
7.3.2.5 - Audit Check Reporting
7.3.2.6 - Ineffective Recalls
7.3.3 - RECALL TERMINATED / RECALL COMPLETED
7.3.3.1 - Definitions
7.3.3.2 - Closeout Inspection
7.4 - SPECIAL RECALL SITUATIONS
7.4.1 - General
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