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Compliance References
Regulatory Procedures Manual 2008
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Table of Contents

INTRODUCTION
1  REGULATORY ORGANIZATION
     1-1  INTRODUCTION
     1-2  OFFICE OF REGULATORY AFFAIRS (ORA)
     1-3  CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
     1-4  CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
     1-5  CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
     1-6  CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN)
     1-7  CENTER FOR VETERINARY MEDICINE (CVM)
     1-8  ENFORCEMENT POLICY DIRECTORY
2  FDA AUTHORITY
     2-1  THE U.S. FEDERAL JUDICIAL SYSTEM
     2-2  SELECTED AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
     2-3  OTHER LAWS
3  COMMISSIONING AND WORK SHARING
     3-1  INTRODUCTION; OBJECTIVES
     3-2  AUTHORITIES
     3-3  CONSIDERATIONS BEFORE COMMISSIONING
     3-4  DOCUMENTATION; CREDENTIALS
     3-5  CONFLICT OF INTEREST
     3-6  CONFIDENTIALITY
     3-7  CONSIDERATIONS AFTER COMMISSIONING
     3-8  ADMINISTRATIVE CONSIDERATIONS
     3-9  ACCEPTING A STATE’S COMMISSION
     3-10  WORK SHARING
     3-11  EXHIBITS
4  ADVISORY ACTIONS
     4-1  WARNING LETTERS
     4-2  UNTITLED LETTERS
     4-3  EXHIBIT
5  ADMINISTRATIVE ACTIONS
     5-1  CITATIONS
     5-2  SECTION 305 MEETING
     5-3  ADMINISTRATIVE DETENTION OF FOOD
     5-4  DETENTION OF FOODS – OTHER STATUTORY AUTHORITY
     5-5  ADMINISTRATIVE DETENTION OF DEVICES
     5-6  LICENSE REVOCATION OR SUSPENSION
     5-7  ORDERS OF RETENTION, RECALL, DESTRUCTION, AND CESSATION OF MANUFACTURING RELATED TO HUMAN CELL, TISSUE, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/PS)
     5-8  CIVIL MONEY PENALTIES
     5-9  EXHIBITS
6  JUDICIAL ACTIONS
     6-1  SEIZURE
     6-2  INJUNCTIONS
     6-3  INSPECTION WARRANTS
     6-4  SEARCH WARRANTS
     6-5  PROSECUTION
     6-6  CIVIL PENALTIES – ELECTRONIC PRODUCT RADIATION CONTROL
     6-7  EXHIBITS
7  RECALL PROCEDURES
     7-1  PURPOSE
     7-2  BACKGROUND
     7-3  SUMMARY OF FDA RESPONSIBILITIES AND PROCEDURES
     7-4  RECALL ENTERPRISE SYSTEM
     7-5  INITIATION OF A RECALL
     7-6  RECALL CLASSIFICATION AND STRATEGY
     7-7  NOTIFICATIONS AND PUBLIC WARNING
     7-8  MONITORING AND AUDITING RECALL EFFECTIVENESS
     7-9  RECALL TERMINATION
     7-10  ATTACHMENTS AND EXHIBITS
8  EMERGENCY PROCEDURES
     8-1  PURPOSE
     8-2  INTRODUCTION
     8-3  RESPONSIBILITY
     8-4  NOTIFICATION OF EMERGENCIES
     8-5  DISTRICT OPERATING PROCEDURE
     8-6  HEADQUARTERS OPERATING PROCEDURES
     8-7  INTERAGENCY COORDINATION
     8-8  PRESS RELATIONS
     8-9  REFERENCES
     8-10  ATTACHMENT AND EXHIBIT
9  IMPORT OPERATIONS AND ACTIONS
     9-1  IMPORT PROCEDURES
     9-2  COVERAGE OF PERSONAL IMPORTATIONS
     9-3  IMPORTATION OF BIOLOGICAL PRODUCTS
     9-4  FDA NATIONAL IMPORT PROCEDURE REGARDING WAREHOUSE ENTRIES
     9-5  RELEASE NOTICES
     9-6  DETENTION WITHOUT PHYSICAL EXAMINATION (DWPE)
     9-7  NOTICE OF DETENTION AND HEARING
     9-8  RESPONSE (HEARING) TO NOTICE OF DETENTION AND HEARING
     9-9  NOTICE OF REFUSAL OF ADMISSION
     9-10  RECONDITIONING
     9-11  SUPERVISORY CHARGES
     9-12  BOND ACTIONS
     9-13  IMPORT INFORMATION DIRECTIVES
     9-14  PRIORITY ENFORCEMENT STRATEGY FOR PROBLEM IMPORTERS
     9-15  IMPORT FOR EXPORT
     9-16  IMPORTATIONS FOR TRADE SHOWS/FAIRS, EXHIBITS AND SPECIAL EVENTS
     9-17  SECURED STORAGE (TEMPORARY REMOVAL DUE TO PENDING REVISION)
     9-18  COMMUNICATION CONCERNING ASSESSMENT OF CIVIL MONETARY PENALTIES BY CBP IN CASES INVOLVING IMPORTED FOOD
     9-19  NOTICE OF SAMPLING
     9-20  GRANTING AND DENYING TRANSPORTATION AND EXPORTATION (T&E) ENTRIES
     9-21  EXHIBITS
10  OTHER PROCEDURES
     10-1  COMMUNICATIONS - DISTRICT AND CENTER RESPONSIBILITIES
     10-2  PRIOR NOTICE
     10-3  REGULATORY MEETINGS
     10-4  INSPECTION OF FOOD RECORDS - SECTIONS 414(A) AND 704(A)
     10-5  ESTABLISHMENT INSPECTION REPORT (EIR) CONCLUSIONS AND DECISIONS
     10-6  INTERSTATE TRAVEL PROGRAM (ITP) CLASSIFICATIONS AND ADMINISTRATIVE ACTIONS
     10-7  REPORTING AND MONITORING
     10-8  AD HOC COMMITTEE
     10-9  APPEAL PROCESS
     10-10  EXPERT SUPPORT FOR CASES
     10-11  TESTIMONY; PRODUCTION OF RECORDS; CERTIFICATION OF RECORDS
     10-12  APPLICATION INTEGRITY POLICY
11  GLOSSARY
APPENDIX A   RPM CHANGE REQUEST FORM
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