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Inspection References
Investigations Operations Manual 2004
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Chapter 8 - RECALL ACTIVITIES

SUBCHAPTER 800 - RECALLS
801 - DEFINITIONS
     801.01 - Recall
     801.02 - Medical Device Notification
     801.03 - Medical Device Safety Alert
     801.04 - Human Tissue for Transplantation
SUBCHAPTER 810 - RECALL NOTIFICATION / INSPECTION
810 - INSPECTION PROCEDURES
     810.01 - Recall Decision Follow-up
811 - FOOD RECALLS
811.01 - Interstate Milk Shippers
812 - MEDICAL DEVICE RECALLS
813 - DRUG RECALLS
     813.01 - Recalls of Human Drug Products
     813.02 - Recalls of Veterinary Drug Products
814 - SAMPLE COLLECTION
815 - RECALL ALERT
816 - RECOMMENDATION FOR RECALL NUMBER
SUBCHAPTER 820 - MONITORING RECALLS
821 - INSPECTIONS TO MONITOR RECALL PROGRESS
822 - FDA RECALL AUDIT CHECKS
     822.01 - Definition
     822.02 - Level of Audit Checks
     822.03 - Sub-Account Checks
     822.04 - Conducting the Check
     822.05 - Audit Check Reporting
     822.06 - Ineffective Recalls
823 - RECALL TERMINATED / RECALL COMPLETED
     823.01 - Definitions
     823.02 - Closeout Inspection
SUBCHAPTER 830 - SPECIAL RECALL SITUATIONS
830 - General

 

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