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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
Appendix
ORA Directory
Change Log
Exhibits
Search
Inspection References
Investigations Operations Manual 2008
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Table of Contents
1.1 - ENGLISH LANGUAGE REQUIREMENT FOR FDA DOCUMENTS
1.2 - TRAVEL
1.3 - LEAVE
1.4 - DISCLOSURE OF OFFICIAL INFORMATION
1.5 - SAFETY
1.6 - PUBLIC RELATIONS, ETHICS & CONDUCT
1.7 - INTERDISTRICT ASSIGNMENTS
1.8 - ORGANIZATION OVERVIEW
1.9 - OFFICE OF REGULATORY AFFAIRS
1.10 - REFERENCES
2.1 - REGULATORY NOTES
2.2 - STATUTORY AUTHORITY
2.3 - RECONDITIONING AND DISTRUCTION
2.4 - CONSENT DECREE
2.5 - DEFAULT DECREE
2.6 - COMPLIANCE ACHIEVEMENT
2.7 - DETENTION ACTIVITIES
2.8 - DENATURING
2.9 - REGULATORY SUBMISSIONS
3.1 - COOPERATIVE EFFORTS
3.2 - FEDERAL AGENCY INTERACTION
3.3 - STATE OPERATIONAL AUTHORITY
3.4 - INTERNATIONAL AGREEMENTS
3.5 - NON GOVERNMENT AGREEMENTS
4.1 - GENERAL
4.2 - DEALER RELATIONS
4.3 - COLLECTION TECHNIQUE
4.4 - DOCUMENTATION & CR
4.5 - SAMPLING: PREPARATION, HANDLING, SHIPPING
5.1 - INSPECTION INFORMATION
5.2 - INSPECTION PROCEDURES
5.3 - EVIDENCE DEVELOPMENT
5.4 - FOOD
5.5 - DRUGS
5.6 - DEVICES
5.7 - BIOLOGICS
5.8 - PESTICIDES
5.9 - VETERINARY MEDICINE
6.1 - IMPORTS
6.2 - IMPORT PROCEDURES
6.3 - REVIEW OF RECORDS
6.5 - IMPORT SAMPLE COLLECTION
6.6 - FILER EVALUATIONS
7.1 - RECALLS
7.2 - RECALL NOTIFICATION / INSPECTION
7.3 - MONITORING RECALLS
7.4 - SPECIAL RECALL SITUATIONS
8.1 - INVESTIGATIONS
8.2 - COMPLAINTS
8.4 - INVESTIGATION - INJURY & ADVERSE REACTION
8.5 - DISASTER PROCEDURES
8.6 - SURVEILLANCE
8.7 - INVESTIGATIONAL RESEARCH
8.8 - COUNTERFEITING/TAMPERING
8.9 - OFFICE OF CRIMINAL INVESTIGATION (OCI)
8.10 - GENERAL INVESTIGATION REPORTING
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