This spiral-bound, 500-page, 8-1/2" x 11" book consists of the official unedited version of the FDA Investigations Operations Manual. The FDA Investigations Operations Manual (IOM) is the primary source of agency policy and procedures for FDA field investigators and inspectors and directs the conduct of all fundamental field investigational activities.
What is the FDA looking for during a facility inspection? This is the book that will tell you.
Who Uses this Book?
Any pharmaceutical/investigational site staff member or department who is or may be subject to an FDA inspection.
What's the Price?
• 1-249 copies: $31.95 • 250-499 copies: $30.95
• 500-749 copies: $29.95 • 750+ copies: $28.95
Custom Cover Prices*?
• 1-24 copies: unavailable • 25-100 copies: $2.00/book
• 100-249 copies: $1.00/book • 250+ copies: No charge
* Based on quantities of a single book title
CHAPTER 1 - ADMINISTRATION
SUBCHAPTER 1.1 ENGLISH LANGUAGE REQUIREMENT FOR FDA DOCUMENTS
SUBCHAPTER 1.2 TRAVEL
SUBCHAPTER 1.3 LEAVE
SUBCHAPTER 1.4 DISCLOSURE OF OFFICIAL INFORMATION
SUBCHAPTER 1.5 SAFETY
SUBCHAPTER 1.6 PUBLIC RELATIONS, ETHICS & CONDUCT
SUBCHAPTER 1.7 INTERDISTRICT ASSIGNMENTS
SUBCHAPTER 1.8 ORGANIZATION OVERVIEW
SUBCHAPTER 1.9 OFFICE OF REGULATORY AFFAIRS
SUBCHAPTER 1.10 REFERENCES
CHAPTER 2 - REGULATORY
SUBCHAPTER 2.1 REGULATORY NOTES
SUBCHAPTER 2.2 STATUTORY AUTHORITY
SUBCHAPTER 2.3 RECONDITIONING AND DESTRUCTION
SUBCHAPTER 2.4 CONSENT DECREE
SUBCHAPTER 2.5 DEFAULT DECREE
SUBCHAPTER 2.6 COMPLIANCE ACHIEVEMENT
SUBCHAPTER 2.7 DETENTION ACTIVITIES
SUBCHAPTER 2.8 DENATURING
SUBCHAPTER 2.9 REGULATORY SUBMISSIONS
CHAPTER 3 - FEDERAL AND STATE COOPERATION
SUBCHAPTER 3.1 COOPERATIVE EFFORTS
SUBCHAPTER 3.2 FEDERAL AGENCY INTERACTION
SUBCHAPTER 3.3 STATE OPERATIONAL AUTHORITY
SUBCHAPTER 3.4 INTERNATIONAL AGREEMENTS
SUBCHAPTER 3.5 NON GOVERNMENT AGREEMENTS
CHAPTER 4 - SAMPLING
SUBCHAPTER 4.1 GENERAL
SUBCHAPTER 4.2 DEALER RELATIONS
SUBCHAPTER 4.3 COLLECTION TECHNIQUE
SUBCHAPTER 4.4 DOCUMENTATION & CR
SUBCHAPTER 4.5 SAMPLING: PREPARATION, HANDLING, SHIPPING
CHAPTER 5 – ESTABLISHMENT INSPECTIONS
SUBCHAPTER 5.1 INSPECTION INFORMATION
SUBCHAPTER 5.2 INSPECTION PROCEDURES
SUBCHAPTER 5.3 EVIDENCE DEVELOPMENT
SUBCHAPTER 5.4 FOOD
SUBCHAPTER 5.5 DRUGS
SUBCHAPTER 5.6 DEVICES
SUBCHAPTER 5.7 BIOLOGICS
SUBCHAPTER 5.8 TOBACCO PRODUCTS
SUBCHAPTER 5.9 VETERINARY MEDICINE
SUBCHAPTER 5.10 REPORTING
CHAPTER 6 - IMPORTS
SUBCHAPTER 6.1 IMPORTS
SUBCHAPTER 6.2 IMPORT PROCEDURES
SUBCHAPTER 6.3 REVIEW OF RECORDS
SUBCHAPTER 6.4 FIELD EXAMINATION
SUBCHAPTER 6.5 IMPORT SAMPLE COLLECTION
SUBCHAPTER 6.6 FILER EVALUATIONS
SUBCHAPTER 6.7 GLOSSARY OF IMPORT TERMS
CHAPTER 7 - RECALL ACTIVITIES
SUBCHAPTER 7.1 RECALLS
SUBCHAPTER 7.2 RECALL NOTIFICATION / INSPECTION
SUBCHAPTER 7.3 MONITORING RECALLS
SUBCHAPTER 7.4 SPECIAL RECALL SITUATIONS
CHAPTER 8 - INVESTIGATIONS
SUBCHAPTER 8.1 INVESTIGATIONS
SUBCHAPTER 8.2 COMPLAINTS
SUBCHAPTER 8.3 INVESTIGATION OF FOODBORNE OUTBREAKS
SUBCHAPTER 8.4 INVESTIGATION - INJURY & ADVERSE
REACTION
SUBCHAPTER 8.5 DISASTER PROCEDURES
SUBCHAPTER 8.6 SURVEILLANCE
SUBCHAPTER 8.7 INVESTIGATIONAL RESEARCH
SUBCHAPTER 8.8 COUNTERFEITING / TAMPERING
SUBCHAPTER 8.9 OFFICE OF CRIMINAL INVESTIGATION (OCI)
SUBCHAPTER 8.10 GENERAL INVESTIGATION REPORTING
ORA DIRECTORY
Click here to see an enlarged pdf cover