FDA Home Page
|
Federal-State
|
Import Program
|
Compliance
|
Inspection
|
Science
|
ORA Search
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
Previous Page
|
Document TOC
|
Chapter TOC
|
Next Page
Contents
8.1 - INVESTIGATIONS
8.2 - COMPLAINTS
8.2.1 - Complaint Categories
8.2.1.1 - Injury/Illness Complaints
8.2.1.2 - Non-Injury/Illness Complaints
8.2.2 - Infant Formula and Baby Food
8.2.3 - Complaints Involving Alcoholic Beverages
8.2.4 - Office of Emergency Operations Guidance
8.2.5 - Interviews
8.2.5.1 - Basic Information to Obtained
8.2.5.2 - Injury/Illness Complaints
8.2.5.3 - Additional Information to Obtain
8.2.5.4 - Complainant Access to Report/Results
8.2.6 - Medical Records
8.2.7 - Sample Collection
8.2.8 - Recording Complaints/Follow-ups
8.3 - INVESTIGATION OF FOODBORNE OUTBREAKS
8.3.1 - FOODBORNE OUTBREAKS
8.3.1.1 - Outbreaks on Foreign Flag Vessels
8.3.1.2 - Outbreaks Involving Interstate Conveyances
8.3.1.3 - Cooperation with Other Agencies
8.3.1.4 - Outbreaks Associated with Salmonella Enteritidis (SE) in Eggs
8.3.2 - FOLLOW-UP GUIDANCE
8.3.2.1 - Preparation
8.3.2.2 - Interviews
8.3.2.2.1 - Contacting the Complainant
8.3.2.2.2 - Setting Communication Level
8.3.2.2.3 - Information to Gather
8.3.2.3 - Medical Records
8.3.3 - SAMPLING PROCEDURES
8.3.3.1 - Sample Collection
8.3.3.2 - Sample Size
8.3.3.3 - Sample Handling
8.3.4 - EPIDEMIOLOGICAL ASSOCIATIONS
8.3.4.1 - Outbreak Determination
8.3.4.2 - Assistance
8.3.4.3 - Additional Case History Interviews
8.3.4.4 - Establishment Investigation
8.3.4.5 - Food Handlers Interviews
8.3.4.6 - Possible Contamination Source
8.3.4.6.1 - Pests
8.3.4.6.2 - Raw Meat
8.3.4.6.3 - Poor Sanitation
8.3.4.6.4 - Workers
8.3.4.7 - Pathogen Growth Factors
8.3.5 - ANALYZING DATA/HYPOTHESIS FORMULATION
8.3.5.1 - Epidemic Curve
8.3.5.2 - Symptoms Determination
8.3.5.3 - Incubation Periods
8.3.5.4 - Attack Rate Table
8.3.5.5 - Tracebacks of Foods Implicated in Foodborne Outbreaks
8.3.6 - REPORTING
8.3.7 - REFERENCES
8.4 - INVESTIGATION - INJURY & ADVERSE REACTION
8.4.1 - INVESTIGATIONS
8.4.1.1 - Procedures
8.4.2 - DRUGS - INJURY OR REACTIONS
8.4.2.1 - Investigative Procedures
8.4.3 - DEVICES - INJURY
8.4.3.1 - Mechanical, Electrical or Electromechanical Devices
8.4.3.2 - Devices for Implant
8.4.3.3 - In Vitro Diagnostic Devices
8.4.3.4 - Investigative Procedures
8.4.3.4.1 - Devices
8.4.3.4.2 - In Vitro Diagnostics
8.4.3.4.3 - Dialysis Injury or Deaths
8.4.4 - BIOLOGICS - INJURY, REACTION OR FATALITY
8.4.4.1 - Professional Reporting System for Vaccine Adverse Reactions
8.4.4.2 - Investigation/Reporting
8.4.5 - FOODS, DIETARY SUPPLEMENTS AND COSMETICS - INJURY OR REACTION
8.4.5.1 - Cosmetics
8.4.5.2 - Dietary Supplements
8.4.5.2.1 - Causes
8.4.5.2.2 - Procedures
8.4.5.3 - Investigation Requirements for Serious Adverse Events of CFSAN Regulated Products
8.4.5.4 - Undeclared Allegen/Allergic Reactions
8.4.6 - VETERINARY PRODUCTS - COMPLAINTS/ADVERSE REACTIONS
8.4.7 - SAMPLE COLLECTION
8.4.7.1 - Device Samples
8.4.7.2 - Biological Samples
8.4.7.3 - Cosmetic Samples
8.4.7.4 - Microbiological Contamination
8.4.7.5 - Allergen Samples
8.4.8 - REPORTING
8.4.8.1 - Reporting Forms
8.4.8.2 - Routing Reports
8.4.8.2.1 - Drugs
8.4.8.2.2 - Medical Device and Radiological Products
8.4.8.2.3 - Foods and Cosmetics
8.4.8.2.4 - Veterinary Products
8.4.8.2.5 - Licensed Biological Products
8.4.8.2.6 - Unlicensed Biologics Product
8.4.8.2.7 - Biologics Injury/Adverse Reaction Reports
8.5 - DISASTER PROCEDURES
8.5.1 - DISASTER TYPES
8.5.2 - RESPONSIBILITY & COORDINATION
8.5.3 - PREPARATION
8.5.4 - PRELIMINARY INVESTIGATION
8.5.5 - FIELD OPERATIONS
8.5.5.1 - Embargoes
8.5.5.2 - Field Examination & Samples
8.5.5.3 - Flooding
8.5.5.4 - Hurricanes & Tornadoes
8.5.5.5 - Fires, Explosions, Riots
8.5.5.6 - Chemical Spills, Hazardous Waste Sites, Wrecks
8.5.5.7 - Earthquakes
8.5.6 - BIOTERRORISM
8.5.7 - PRODUCT DISPOSITION
8.5.7.1 - Segregation
8.5.7.2 - Destruction
8.5.7.3 - Reconditioning
8.5.7.4 - Relabeling
8.5.7.5 - Ammonia Leaks
8.5.7.6 - Perishable Products
8.5.7.7 - Reconditioning Plastic, Paper, Cardboard, Cloth and Similar Containers
8.5.7.8 - Reconditioning Screw-top, Crimped-cap, and Similar Containers
8.5.7.9 - Reconditioning Hermetically Sealed (Top & Bottom Double Seam) Cans
8.5.7.10 - Reconditioning Devices
8.5.8 - REPORTING
8.6 - SURVEILLANCE
8.6.1 - Surveillance Procedures
8.6.2 - FDA 457 PREPARATION
8.6.3 - FDA 457 ROUTING
8.7 - INVESTIGATIONAL RESEARCH
8.7.1 - RESEARCH ASSIGNMENTS
8.7.2 - JOINT RESEARCH PROJECTS
8.7.3 - RESEARCH PROJECT IDENTIFICATION CODE
8.7.4 - RESEARCH PROJECT PROGRESS REPORTS
8.7.5 - TERMINATION OF RESEARCH PROJECTS
8.7.6 - PRIORITY
8.7.7 - DATA REPORTING
8.8 - COUNTERFEITING/TAMPERING
8.8.1 - REPORTING CONTACTS
8.8.1.1 - OCM / OEO RESPONSIBILITY
8.8.2 - COORDINATION WITH OTHER GOVERNMENT AGENCIES
8.8.3 - AUTHORITY & RESPONSIBILITY
8.8.4 - RELEASE OF INFORMATION
8.8.5 - INVESTIGATION
8.8.5.1 - General Procedures
8.8.5.2 - Interviews
8.8.5.3 - Sampling
8.8.5.4 - Complainants
8.8.5.5 - Retail Stores
8.8.5.6 - Manufacturer and Distribution System Follow-up
8.8.5.6.1 - Manufacturing Sites
8.8.5.6.2 - Distribution Facilities
8.8.5.6.3 - Security
8.8.6 - RECORD REQUESTS
8.8.7 - REFUSALS
8.8.8 - REPORTING
8.9 - OFFICE OF CRIMINAL INVESTIGATION (OCI)
8.9.1 - OCI PROCEDURES
8.9.1.1 - Reports of Criminal Activity
8.9.1.2 - Liaison with Law Enforcement / Intelligence Community
8.9.1.3 - Consensual Electronic Surveillance
8.9.1.4 - Postal Mail Cover
8.10 - GENERAL INVESTIGATION REPORTING
Page Top
Previous Page
|
Document TOC
|
Chapter TOC
|
Next Page
