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Inspection References
Investigations Operations Manual 2004
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Contents

SUBCHAPTER 200 - ORGANIZATION OVERVIEW
201 - FDA PRINCIPLES

SUBCHAPTER 200 - ORGANIZATION OVERVIEW

A complete description of the FDA's organizational structure and its functional statement is found in various chapters of the Staff Manual Guides (SMG) which are available on FDA's Intranet Website see [Intranet Only Link].

The FDA is a part of the Department of Health and Human Services (HHS). An appointed Commissioner who serves at the discretion of the President heads the agency.

There are approximately 9300 FDA employees.

The FDA is a team of dedicated professionals working to protect and promote the health of the American people.

FDA is responsible for ensuring:

Foods are safe, wholesome, and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe.

Regulated products are honestly, accurately, and informatively represented.

These products are in compliance with the law and FDA regulations; noncompliance is identified and corrected; and any unsafe or unlawful products are removed from the marketplace.

201 - FDA PRINCIPLES

We strive to:

Enforce FDA laws and regulations, using all appropriate legal means.

Base regulatory decisions on a strong scientific and analytical base and the law; and understand, conduct, and apply excellent science and research.

Be a positive force in making safe and effective products available to the consumer, and focus special attention on rare and life-threatening diseases.

Provide clear standards of compliance to regulated industry, and advise industry on how to meet those standards.

Identify and effectively address critical public health problems arising from use of FDA-regulated products.

Increase FDA's effectiveness through collaboration and cooperation with state and local governments; domestic, foreign, and international agencies; industry; and academia.

Assist the media, consumer groups, and health professionals in providing accurate, current information about regulated products to the public.

Work consistently toward effective and efficient application or resources to our responsibilities,

Provide superior public service by developing, maintaining, and supporting a high-quality, diverse workforce.

Be honest, fair, and accountable in all our actions and decisions.

 

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