FDA检查操作手册2025 (Word版本)

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TABLE OF CONTENTS

CHAPTER 1 – ADMINISTRATIVE

SUBCHAPTER 1.1 - ADMINISTRATION NOTES SUBCHAPTER 1.2 - OII 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 1.10  BUSINESS CARDS

SUBCHAPTER 1.10 - ETHICS AND INTEGRITY

SUBCHAPTER 1.12 - QUALITY MANAGEMENT SUBCHAPTER 1.13 - OII TIME REPORTING

CHAPTER 2 – NOTES, RECORDS, AND INFORMATION

SUBCHAPTER 2.1 - REGULATORY NOTES

SUBCHAPTER 2.2 - RECORDS MANAGEMENT

SUBCHAPTER 2.3   INFORMATION DISCLOSURE

SUBCHAPTER 2.4 - ENGLISH LANGUAGE REQUIREMENT SUBCHAPTER 2.5 - FULL NAME REQUIREMENT

CHAPTER 3 - REGULATORY

SUBCHAPTER 3.1 - PURPOSE

SUBCHAPTER 3.2 - STATUTORY AUTHORITY SUBCHAPTER 3.3 - EVIDENCE

SUBCHAPTER 3.4 - ADVISORY ACTIONS AND OTHER NOTICES OF VIOLATIONS SUBCHAPTER 3.5 - ADMINISTRATIVE ACTIONS

SUBCHAPTER 3.6 - PROCEDURAL STEPS FOR EXECUTION OF DETENTION AT A FIRM SUBCHAPTER 3.7 - DENATURING

SUBCHAPTER 3.8 - JUDICIAL ACTIONS

SUBCHAPTER 3.9 - COMPLIANCE ACHIEVEMENTS FOR VOLUNTARY CORRECTIVE ACTIONS

SUBCHAPTER 3.10 - REGULATORY SUBMISSIONS SUBCHAPTER 3.11 – REFERENCES

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 - INSPECTIONS

SUBCHAPTER 5.1 - GENERAL INSPECTION INFORMATION

SUBCHAPTER 5.2 - PRE-INSPECTION ACTIVITIES

SUBCHAPTER 5.3 - SAFETY DURING INSPECTIONS

SUBCHAPTER 5.4 - CONFIDENTIAL SOURCES   SUBCHAPTER 5.5 - INSPECTIONAL ACTIVITIES SUBCHAPTER 5.6 - EVIDENCE DEVLOPEMENT SUBCHAPTER 5.7 - REPORTING

SUBCHAPTER 5.8 - HUMAN AND ANIMAL FOODS SUBCHAPTER 5.9 - COSMETICS

SUBCHAPTER 5.10 - DRUGS

SUBCHAPTER 5.11 - ANIMAL & VETERINARY

SUBCHAPTER 5.12 - MEDICAL DEVICE AND ELECTRONIC     RADAIATION PRODUCT CONTROL (EPRC)

SUBCHAPTER 5.13 - BIOLOGICS

SUBCHAPTER 5.14 - BIORESEARCH MONITORING (BIMO) SUBCHAPTER 5.15 - TOBACCO PRODUCTS

SUBCHAPTER 5.16 - COMBINATION PRODUCTS

CHAPTER 6 - IMPORTS

SUBCHAPTER 6.1 - IMPORT GENERAL

SUBCHAPTER 6.2 - ENTRY REVIEW

SUBCHAPTER 6.3 - FIELD EXAMINATION

SUBCHAPTER 6.4 - IMPORT SAMPLE COLLECTION

SUBCHAPTER 6.5 - IMPORT PROCEDURS AFTER EXAMINATION / SAMPLING SUBCHAPTER 6.6 - IMPORT INVESTIGATIONS

SUBCHAPTER 6.7 - FILER EVALUATIONS

SUBCHAPTER 6.8 - FOREIGN SUPPLIER VERIFICATION PROGRAM (FSVP) SUBCHAPTER 6.9 - GLOSSERY OF IMPORT TERMS

CHAPTER 7 - RECALL ACTIVITIES

SUBCHAPTER 7.1 - PURPOSE OF RECALLS

SUBCHAPTER 7.2 - RESPONSIBILITIES DURING RECALLS

SUBCHAPTER 7.3 - RECALLS AND INSPECTIONS

SUBCHAPTER 7.4 - FDA’S RECALL MONITORING ACTIVITIES

SUBCHAPTER 7.5 - RECALL COMPLETION AND TERMINATION

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

CHAPTER 9 – PUBLIC HEALTH COLLABORATION

SUBCHAPTER 9.1 - PUBLIC HEALTH COLLABORATION

SUBCHAPTER 9.2 - ROLES AND RESPONSIBILITES OF OTHER FEDERAL AGENCY SUBCHAPTER 9.3 - STATE LOCAL, TRIBAL AND TERRITORIAL INTERACTIONS

SUBCHAPTER 9.4 - INTERNATIONAL AGREEMENTS

SUBCHAPTER 9.5 - NON-GOVERNMENT AGREEMENTS SUBCHAPTER 9.6 - TRIBAL AFFAIRS

CHAPTER 10 – SAFETY

SUBCHAPTER 10.1 - PURPOSE

SUBCHAPTER 10.2 - UNACCEPTABLE RISK SUBCHAPTER 10.3 - PERSONAL SAFETY

SUBHCAPTER 10.4 - EMPLOYER/EMPLOYEE SAFETY     RESPONSIBILITIES SUBCHAPTER 10.5 - FOLLOWING FIRM SAFETY  REQUIREMENTS

SUBCHAPTER 10.6 - SAFETY RISK ASSESMENT FRAMEOWRKS SUBCHAPTER 10.7 - ADDITIONAL SAFETY INFORMATION

SUBCHAPTER 10.8 - HIERARCHY OF CONTENTS

SUBCHAPTER 10.9 - PPE

SUBCHAPTER 10.10 - REGULATORY OPERATIONS SAFETY      STAFF (ROSS)

SUBCHAPTER 10.11 - RESOURCES

SUBCHAPTER 10.12 - SPECIAL SAFETY SITUATIONS SUBCHAPTER 10.13 - BIOLOGICAL HAZARDS

SUBCHAPTER 10.14 - CHEMICAL HAZARDS

SUBCHAPTER 10.15 - PHYSICAL AND RADITION HAZARDS SUBCHAPTER 10.16 - ERGONOMIC

SUBCHAPTER 10.17 - EMPLOYEE AND TRAVELER HEALTH AND SAFETY

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)

Note: Certain links in this chapter are only available to FDA employees via the FDA

Intranet site and cannot be accessed by individuals outside the FDA internal network.

Requests for information can be made through the Freedom of Information Act (FOIA)

process described in IOM Section 8.1.3 and also athttps://www.fda.gov/regulatory-    information/freedom-information/how-make-foia-request.

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