INVESTIGATIONS OPERATIONS MANUAL 2023 TABLE OF CONTENTS

TABLE OF CONTENTS 2023 

CHAPTER S – SAFETY

SUBCHAPTER S.1 PURPOSE 

SUBCHAPTER S.2 UNACCEPTABLE RISK

SUBCHAPTER S.3 PERSONAL SAFETY

SUBHCAPTER S.4 EMPLOYER/EMPLOYEE SAFETY 

RESPONSIBILITIES 

SUBCHAPTER S.5 FOLLOWING FIRM SAFETY 

REQUIREMENTS

SUBCHAPTER S.6 SAFETY RISK ASSESMENT 

FRAMEOWRKS 

SUBCHAPTER S.7 ADDITIONAL SAFETY INFORMATION

SUBCHAPTER S.8 HIERARCHY OF CONTROLS

SUBCHAPTER S.9 PPE 

SUBCHAPTER S.10 ORA SAFETY OFFICE

SUBCHAPTER S.11 RESOURCES

SUBCHAPTER S.12 SPECIAL SAFETY SITUATIONS

SUBCHAPTER S.13 BIOLOGICAL HAZARDS

SUBCHAPTER S.14 CHEMICAL HAZARDS

SUBCHAPTER S.15 PHYSICAL AND RADITION HAZARDS

SUBCHAPTER S.16 ERGONOMIC

SUBCHAPTER S.17 EMPLOYEE AND TRAVELER HEALTH 

AND SAFETY

CHAPTER 1 – ADMINISTRATION

SUBCHAPTER 1.1 ADMINISTRATION NOTES 

SUBCHAPTER 1.2 ORA TRAVEL 

SUBCHAPTER 1.3 TRAVELER’ HEALTH

SUBCHAPTER 1.4 DIVISION OF TRAVEL OPERATIONS

SUBCHAPTER 1.5 VEHICLE ACCIDENTS 

SUBCHAPTER 1.6 TRANSPORTATION

SUBCHAPTER 1.7 MEDIA INTERACTIONS DURING

 INSPECTIONS 

SUBCHAPTER 1.8 EQUIPMENT 

SUBCHAPTER 1.9 OFFICAL IDENTIFICIATION 

SUBCHAPTER 2.1 PURPOSE 

SUBCHAPTER 2.2 STATUTORY AUTHORITY

SUBCHAPTER 2.3 EVIDENCE

SUBCHAPTER 2.4 ADVISORY ACTIONS AND OTHER 

NOTICES OF VIOLATIONS

SUBCHAPTER 2.5 ADMINISTRATIVE ACTIONS

SUBCHAPTER 2.6 PROCEDURAL STEPS FOR 

EXECUTION OF DETENTION AT A FIRM 

SUBCHAPTER 2.7 DENATURING

SUBCHAPTER 2.8 JUDICIAL ACTIONS

SUBCHAPTER 2.9 COMPLIANCE ACHIEVEMENTS FOR 

VOLUNTARY CORRECTIVE ACTIONS

SUBCHAPTER 2.10 REGULATORY SUBMISSIONS 

SUBCHAPTER 2.11 REFERENCES

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 DOCUMENTS COLLECTED WITH 

SAMPLE 

SUBCHAPTER 4.5 BIORESEARCH MONITORING 

SAMPLES 

SUBCHAPTER 4.6 REPORTING SAMPLE COLLECTIONS

SUBCHAPTER 4.7 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 BIORESERACH MONITORING (BIMO) 

SUBCHAPTER 5.11 REPORTING

CHAPTER 6 - IMPORTS

SUBCHAPTER 6.1 IMPORTS

SUBCHAPTER 6.2 IMPORT PROCEDURES

SUBCHAPTER 6.3 ENTRY REVIEW

SUBCHAPTER 6.4 FIELD EXAMINATION

SUBCHAPTER 6.5 IMPORT SAMPLE COLLECTION

SUBCHAPTER 6.6 FILER EVALUATIONS

SUBCHAPTER 6.7 GLOSSARY OF IMPORT TERMS

SUBCHAPTER 6.8 FOREIGN SUPPLIER VERIFICATION 

PROGRAM

SUBCHAPTER 6.9 FSVP REPORTING

SUBCHAPTER 1.10 BUSINESS CARDS 

SUBCHAPTER 1.11 ETHICS AND INTEGRITY

SUBCHAPTER 1.12 QMiS

SUBCHAPTER 1.13 ORA TIME REPORTING

CHAPTER 1A – NOTES, RECORDS, AND

INFORMATION

SUBCHAPTER 1A.1 REGULATORY NOTES 

SUBCHAPTER 1A.2 RECORDS MANAGEMENT

SUBCHAPTER 1A.3 INFORMATION DISCLOSURE 

SUBCHAPTER 1A.4 ENGLISH LANGUAGE REQUIREMENT 

SUBCHAPTER 1A.5 FULL NAME REQUIREMENT

CHAPTER 2 - REGULATORY
TABLE OF CONTENTS INVESTIGATIONS OPERATIONS MANUAL 2023

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 AND INSPECTIONS

SUBCHAPTER 8.2 HUMAN AND ANIMAL FOOD 

INVESTIGATIONS 

SUBCHAPTER 8.3 DRUG INVESTIGATIONS

SUBCHAPTER 8.4 DEVICE INVESTIGATIONS 

SUBCHAPTER 8.5 BIOLOGICS INVESTIGATIONS

SUBCHAPTER 8.6 BIORESEARCH MONITORING 

INVESTIGATIONS 

SUBCHAPTER 8.7 TOBACCO INVESTIGATIONS

APPENDIX

APPENDIX A PRINCIPAL STORED GRAIN INSECTS

APPENDIX B PERPETUAL JULIAN CALENDAR

APPENDIX C BLOOD SERUM CHEMISTRY

APPENDIX D CONVERSION TABLES

APPENDIX E DIVISION MAPS (OBIMO, OBPO, 

OMDRHO, OPQO, OHAFO, OEIO, 

TOBACCO, ORS)

INDEX

NOTES