Regulatory Procedures Manual

INTRODUCTION

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This chapter includes the following sections: 

Section Topic Page

1. Purpose ..................................................................................................... 1

2. Scope......................................................................................................... 1

3. Responsibility............................................................................................. 1

4. Background................................................................................................ 1

5. Attachment - Vision, Mission and Values................................................... 3

1. Purpose

The Regulatory Procedures Manual (RPM) is a reference manual that 

provides internal procedures and related information to be used by FDA 

employees who process certain regulatory and enforcement matters in 

support of the agency's public health mission. Adherence to this manual is 

paramount to assure quality, consistency, and efficiency in FDA 

operations.

2. Scope

Other FDA manuals and guidance supplement, but do not supersede, the 

information in this manual. We recognize this manual will not address all 

situations encountered in the performance of compliance-related activities. 

In such cases, your division management must be informed and concur 

with any significant departures from the RPM.

The RPM does not create or confer any rights for or on any person and 

does not operate to bind FDA or the public.

3. Responsibility

While the RPM is intended mainly to describe procedures for FDA 

investigation and compliance officers, and programs and divisions in ORA, 

the document is useful to all of FDA.

4. Background

This version of the RPM contains important changes which clarify or 

present new information and procedures. For example, this year we have 
Regulatory Procedures Manual November 2019 Introduction

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included information relating to the recent Program Alignment changes. 

We are continuing to update the RPM in response to our May 15, 2017 

rollout of program alignment across ORA. These program alignment

updates will continue as we incorporate new program-specific sections 

within the RPM. As with each new edition of the RPM, please take time to 

review sections of the manual for changes which may apply to your work. 

We are committed to the continual improvement of the quality and 

usefulness of the RPM. Suggestions for the next edition of the RPM or 

recommended changes, deletions, additions to the RPM may be sent via 

e-mail to the Outlook address for ORA RPM Updates. If you are 

recommending a change or revision, please use the RPM Change 

Request Form available at RPM Appendix A. Suggestions are accepted 

from the within the Agency, our state and local partners, industry and 

consumers. Thank you for your continued hard work and dedication in 

protecting and promoting the health and well-being of the American 

people.

The RPM has been posted on ORA's Internet Website at 

https://www.fda.gov/inspections-compliance-enforcement-and-criminalinvestigations/compliance-manuals/regulatory-procedures-manual. Future 

updates to the RPM will be performed periodically during the year to the 

on-line version. Remember, whether reviewing a printed copy or the online version of the RPM, the most recent version on line is the document of 

record.
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5. Attachment - Vision, Mission and Values

Vision

All food is safe; all medical products are safe and effective; and the public 

health is advanced and protected. 

Mission

Protecting consumers and enhancing public health by maximizing 

compliance of FDA regulated products and minimizing risk associated with 

those products. Quality Commitment ORA is committed to quality and 

continual improvement. Our actions are dedicated to effectively meeting 

our customers' needs. 

Values

Accountability - We take personal responsibility for meeting individual,

team, and organizational commitments

Commitment to Public Health - We demonstrate our commitment to 

safeguarding the public health in our actions.

Communication - We provide information that is accurate and clear, and in 

our interactions with others, we actively listen to understand other points 

of view.

Diversity & Inclusion - We embrace each individual's uniqueness and seek 

out their ideas and perspectives.

Integrity and Respect - We adhere to the highest ethical standards by 

consistently being honest and trustworthy in our actions. 

Quality - We set high standards of excellence for our work and take the 

necessary actions to continuously improve.