Skip page top navigationFDA Logo--links to FDA home page Logo of and Link to start page of Office of Regulatory Affairs, U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Compliance Ref | Federal-State | Inspection Ref | Import Program | Science Ref | ORA Search


Inspection References
Investigations Operations Manual 2004
Previous Page | Document TOC | Chapter TOC | Next Page


Chapter 9 - INVESTIGATIONS

SUBCHAPTER 900 - INVESTIGATIONS
901 - INVESTIGATIONS GENERAL
SUBCHAPTER 902 - Complaints
902 - COMPLAINTS - GENERAL
     902.01 - Complaint Categories
     902.02 - Infant Formula and Baby Food
     902.04 - Complaints Involving Alcoholic Beverages
     902.05 - Emergency Operations Center Guidance
     902.06 - Interviews
     902.07 - Medical Records
     902.08 - Sample Collection
     902.09 - Recording Complaints/Follow-ups
SUBCHAPTER 910 - INVESTIGATION OF FOODBORNE OUTBREAKS
910 - FOODBORNE OUTBREAKS
     910.01 - Outbreaks on Foreign Flag Vessels
     910.02 - Outbreaks Involving Interstate Conveyances
     910.03 - Cooperation with Other Agencies
910.04 - Outbreaks Associated with Salmonella Enteritidis (SE) in Eggs
911 - FOLLOW-UP GUIDANCE
912 - SAMPLING PROCEDURES
     912.01 - Sample Collection
     912.02 - Sample Size
     912.03 - Sample Handling
913 - EPIDEMIOLOGICAL ASSOCIATIONS
     913.01 - Outbreak Determination
     913.02 - Assistance
     913.03 - Additional Case History Interviews
     913.04 - Establishment Investigation
     913.05 - Food Handlers Interviews
     913.06 - Possible Contamination Source
     913.07 - Pathogen Growth Factors
914 - ANALYZING DATA/HYPOTHESIS FORMULATION
     914.01 - Epidemic Curve
     914.02 - Symptoms Determination
     914.03 - Incubation Periods
     914.04 - Attack Rate Table
     914.05 - Tracebacks of Foods Implicated in Foodborne Outbreaks
915 - REPORTING
916 - REFERENCES
SUBCHAPTER 920 - INVESTIGATION - INJURY & ADVERSE REACTION
921 - INVESTIGATIONS
922 - DRUGS - INJURY OR REACTIONS
923 - DEVICES - INJURY
     923.01 - Mechanical, Electrical or Electromechanical Devices
     923.02 - Devices for Implant
     923.03 - In Vitro Diagnostic Devices
     923.04 - Investigative Procedures
924 - BIOLOGICS - INJURY, REACTION OR FATALITY
     924.01 - Professional Reporting System for Vaccine Adverse Reactions
     924.02 - Investigation/Reporting
925 - FOODS, DIETARY SUPPLEMENTS AND COSMETICS - INJURY OR REACTION
     925.01 - Cosmetics
     925.02 - Dietary Supplements
     925.03 - Investigation Requirements for Serious Adverse Events of CFSAN Regulated Products
926 - VETERINARY PRODUCTS - COMPLAINTS/ADVERSE REACTIONS
927 - SAMPLE COLLECTION
928 - REPORTING
SUBCHAPTER 940 - DISASTER PROCEDURES
941 - DISASTER TYPES
942 - RESPONSIBILITY & COORDINATION
943 - PREPARATION
944 - PRELIMINARY INVESTIGATION
945 - FIELD OPERATIONS
     945.01 - Embargoes
     945.02 - Field Examination & Samples
     945.03 - Flooding
     945.04 - Hurricanes & Tornadoes
     945.05 - Fires, Explosions, Riots
     945.06 - Chemical Spills, Hazardous Waste Sites, Wrecks
     945.07 - Earthquakes
946 - BIOTERRORISM
947 - PRODUCT DISPOSITION
     947.01 - Reconditioning
     947.02 - Relabeling
     947.03 - Ammonia Leaks
     947.04 - Perishable Products
     947.05 - Reconditioning Plastic, Paper, Cardboard, Cloth and Similar Containers
     947.06 - Reconditioning Screw-top, Crimped-cap, and Similar Containers
     947.07 - Reconditioning Hermetically Sealed (Top & Bottom Double Seam) Cans
     947.08 - Reconditioning Devices
948 - REPORTING
SUBCHAPTER 950 - SURVEILLANCE
950 - SURVEILLANCE PROCEDURES
951 - FDA 457 PREPARATION
952 - FDA 457 ROUTING
SUBCHAPTER 960 - INVESTIGATIONAL RESEARCH
961 - RESEARCH ASSIGNMENTS
962 - JOINT RESEARCH PROJECTS
963 - RESEARCH PROJECT IDENTIFICATION CODE
964 - RESEARCH PROJECT PROGRESS REPORTS
965 - TERMINATION OF RESEARCH PROJECTS
966 - PRIORITY
967 - DATA REPORTING
SUBCHAPTER 970 - COUNTERFEITING/TAMPERING
971 - REPORTING CONTACTS
     971.01 - OCM / EOC RESPONSIBILITY
972 - COORDINATION WITH OTHER GOVERNMENT AGENCIES
973 - AUTHORITY & RESPONSIBILITY
974 - RELEASE OF INFORMATION
975 - INVESTIGATION
     975.01 - General Procedures
     975.02 - Interviews
     975.03 - Sampling
     975.04 - Complainants
     975.05 - Retail Stores
     975.06 - Manufacturer and Distribution System Follow-up
976 - RECORD REQUESTS
977 - REFUSALS
978 - REPORTING
SUBCHAPTER 980 - OFFICE OF CRIMINAL INVESTIGATION (OCI)
981 - OCI PROCEDURES
     981.01 - Reports of Criminal Activity
     981.02 - Liaison with Law Enforcement / Intelligence Community
     981.03 - Consensual Electronic Surveillance
     981.04 - Postal Mail Cover
SUBCHAPTER 990 - GENERAL INVESTIGATION REPORTING

 

Page Top Previous Page | Document TOC | Chapter TOC | Next Page