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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Inspections

Introduction

Introduction

 

CONTENTS

  1. History

    The Food and Drug Administration (FDA) has been performing international inspections in support of the Food and Drug Act since 1955. Up until 1983, no written Standard Operating Procedures (SOP) existed for this program. In January 1983, an SOP was prepared, but it was not regularly updated and revised. A formal manual entitled "FDA/ORA Foreign Inspection Manual and Travel Guide" was published in February 1993 and it was subsequently revised in June 1994. During the revision in May 1997, the title was changed to "FDA/ORA International Inspection Manual and Travel Guide." In July 1999, the Guide was converted into an electronic format and the title was changed to "Guide to International Inspections and Travel."

    This is an up-date of the July 1999 revision. The entire document has been reorganized from seven to four chapters and the entire Guide including the exhibits is in WORD format. It is available from the internet:

    http://www.fda.gov/ICECI/Inspections/ForeignInspections/default.htm.

    The title remains unchanged. This guide is intended to meet the needs of the Agency, Division of Field Investigations (DFI), and Office of Regulatory Affairs (ORA) travelers.

  2. Objectives

     

    The Guide to International Inspections and Travel is intended to assist in fulfilling FDA's overall mission of assuring that drug, medical device, biological, and food products manufactured in foreign countries and intended for U.S. distribution are in compliance with the law and regulations; that non-compliance is identified and corrected; and that any unsafe or unlawful products are removed from the marketplace.

    This guide provides FDA personnel with standard operational, inspectional, and investigational procedures when conducting international inspections. It provides instructions and references to assist investigators and analysts who conduct international inspections. It contains information regarding authorities, objectives, responsibilities, policies, and guides applicable to inspectional operations, administrative procedures, and the basic guidance necessary for FDA personnel who travel to foreign countries.

    This guide is not designed to be all-inclusive, nor unduly restrictive. The procedures and guides
    contained herein are to supplement the experience, skill and proficiency of investigators and analysts and serve as a reference.

    This guide was developed with the help of experienced international travelers. Anyone may propose and/or submit material to DFI that they feel would be beneficial to ORA’s international inspection program. Before submitting any material for inclusion into this guide, contact DFI, at 301-827-5653 for assistance and guidance.

    Certain policies and procedures applicable to a particular compliance program, or found in the Investigations Operations Manual (IOM) may not be repeated in this guide. Refer to the Compliance Program Guidance Manual and/or the IOM for this information.

  3. ORA Vision

     

    We are an empowered, flexible public health team that is customer oriented and results driven to produce high quality work and develop innovative ways to leverage resources. We focus on assuring compliance of FDA regulated products to achieve consumer protection.

  4. ORA Mission

     

    Achieve effective and efficient compliance of regulated products through high quality, science-based work that results in maximizing consumer protection.

  5. ORA Core Values

     

    • We value our people
    • We are a public health agency with law enforcement responsibilities
    • There are many knowledgeable, dedicated people in government agencies and industry
    • Properly trained, empowered employees who are held accountable can produce high quality work
    • Outcomes are important
    • The changes are here to stay—Government Reinvention makes common sense and can be applied to make ORA a more effective organization--we are under a mandate to change.
    • Most of industry shares the same goal as FDA to produce safe and effective products.
    • Corrective action is our goal through the most efficient means--using more stringent actions for those who will not comply.
    • We achieve compliance not only with enforcement actions, but also with tools such as: workshops, meetings, and joint problem solving.
    • We must recognize that we will do less with, and must prioritize what we do, considering the needs and expectations of our customers
    • Everyone contributes to the solution.

 

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Note: This guide is a reference material for ORA field investigators and other FDA personnel. The document does not bind FDA and does not confer any rights, privileges, benefits or immunities for or on any person(s).