REGULATORY PROCEDURES MANUAL

CONTENTS

INTRODUCTION....................................................................vii

CHAPTER 1 - REGULATORY ORGANIZATION

Office of Regulatory Affairs ........................................................ 2

Center for Biologics and Research ................................................... 4 

Center for Drug Evaluation and Research ............................................. 6 

Center for Devices and Radiological Health .......................................... 8 

Center for Food Safety and Applied Nutrition ........................................ 9 

Center for Veterinary Medicine ......................................................12 

Enforcement Policy Directory ........................................................15 

CHAPTER 2 - FDA AUTHORITY

Selected Amendments to the Federal Food, Drug, and Cosmetic Act .....................33

Other Laws ..........................................................................40

CHAPTER 3 - OTHER REGULATORY AGENCIES

Commissioning State and Local Officials..............................................45

Work Sharing Agreements..............................................................54

CHAPTER 4 - ADVISORY ACTIONS/

Warning Letters......................................................................79

Untitled Letters.....................................................................95

CHAPTER 5 - ADMINISTRATIVE ACTIONS

Citations............................................................................131

Detentions...........................................................................136

Administrative Detentions of Devices.................................................138

License Revocation and Suspension....................................................145

Section 305 Meeting..................................................................148

CHAPTER 6 - JUDICIAL ACTIONS

Seizure..............................................................................173

Injunctions..........................................................................186

Inspection Warrants..................................................................198

Search Warrants......................................................................200

Prosecutions.........................................................................202

CHAPTER 7 - RECALL PROCEDURES

Recall Procedures....................................................................271

CHAPTER 8 - INFORMATION DISCLOSURE

Expert Witness.......................................................................315

Testimony............................................................................316

FOIA.................................................................................318

CHAPTER 9 - IMPORT OPERATIONS/ACTIONS

Import Procedures....................................................................338

Release Notices......................................................................344

Automatic Detention..................................................................345

Notice of Detention and Hearing......................................................353

Response to Notice of Detention and Hearing..........................................354

Notice of Refusal of Admission.......................................................356

Reconditioning.......................................................................358

Supervisory Charges..................................................................361

Bond Actions.........................................................................362

Import Information Directives........................................................364

Priority Enforcement Strategy for Problem Importers..................................366



CHAPTER 10 - OTHER PROCEDURES

Prior Notice ........................................................................375

EIR Conclusions and Decisions........................................................376

ITS and Support Facilities- Classifications and Administrative Actions...............379

Reporting and Monitoring.............................................................380

Ad Hoc Committee.....................................................................382

Appeal Process ......................................................................384

 CHAPTER 11 - GLOSSARY AND DEFINITIONS 

General Terms and Definitions........................................................387

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INTRODUCTION

The purpose of this chapter is to provide an overview of the organizational structure of the offices involved in compliance related functions within the Food and Drug Administration. It is not the intent to provide a complete description as a complete description of the FDA's organizational structure and its functional statement are found in various chapters of the FDA Staff Manual Guide (SMG). This RPM chapter is divided into sections based on major organizational units, and includes a section for all centers and the Office of Regulatory Affairs. An "enforcement policy" directory, has also been provided at the end of the chapter.

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