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CONTENTS
- 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/ora/inspection_ref/giit/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.
- 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.
- 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.
- ORA Mission
Achieve effective and efficient compliance of regulated products
through high quality, science-based work that results in maximizing
consumer protection.
- 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).
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