CONTENTS
Subchapter 100 - GENERAL
101 STAFFING
102 LOCATION
Subchapter 110 - RESPONSIBILITIES
111 RECRUITMENT OF INTERNATIONAL INSPECTION CADRE MEMBERS
112 PLANNING INSPECTION TRIPS
112.1 INSPECTION REQUESTS
112.2 NUMBER AND TYPES OF FIRMS TO BE INSPECTED
112.3 LENGTH OF TRIP
112.4 TRIP LOCALE
112.5 SELECTION OF INVESTIGATOR/ ANALYSTS
112.6 FIRM/AGENT CONTACT
112.7 DISTRICT CONTACT
112.8 HEADQUARTERS COORDINATION
112.9 LABORATORY COORDINATION
113 TRIP FOLDER
113.1 ITINERARY
113.2 INTERNATIONAL ASSIGNMENT PLANNERS
113.3 PASSPORT/VISA
113.4 AIRLINE TICKETS
113.5 ADVANCE OF FUNDS
113.6 REFERENCE MATERIALS
114 BRIEFING
115 DEBRIEFING
116 TRAINING
117 NON-INSPECTIONAL REGULATORY TRAVEL
SUBCHAPTER 100 - GENERAL
The international inspection program began in 1955 with the inspection and
certification of certain antibiotic firms in Europe. The regulations covering
antibiotics required certification of each batch of antibiotics both domestic
and foreign. This made it necessary to review the foreign firm's documentation,
methods and controls on-site.
In the early 1970s, the agency began to conduct inspections
of foreign prescription and bulk drug manufacturers identified
in NDA and ANDA submissions.
As a result of the 1976 medical device amendment to the FD&C
Act, foreign medical device and diagnostic manufacturers were
also included in the international inspection program. The
first international medical device inspection was conducted
in 1975.
Since 1977, FDA has inspected foreign toxicological laboratories
and other facilities involved in the pre NDA approval testing
of new drugs, to assure compliance with the Good Laboratory
Practices (GLPs) requirements.
International work in the food area was basically limited
to "hazard to health" inspections of LACF, and
infant formula firms. In 1992, the Office of Seafood, CFSAN,
and ORA started inspections of foreign seafood facilities
and increased the coverage of LACF facilities located outside
the U.S.
101 STAFFING
The international inspection program is managed by the Division
of Field Investigations (DFI), Office of Regional Operations
within the Office of Regulatory Affairs. Within DFI, the day-to-day
operations regarding international inspections, global harmonization
and related international activities are performed by the International
Operations Branch (IOB). The IOB consists of Consumer Safety
Officers (CSOs) and Program Specialists (PSs).
102 LOCATION
DFI is located in the Parklawn Building. The mailing address is:
Food and Drug Administration
Division of Field Investigations (DFI), HFC-130 5600 Fishers Lane, Room 13-64
Rockville, MD 20857 U. S. A.
Telephone: (301) 827-5653.
Fax: (301)443-3757, (301) 443-6919, and (301) 827-6685
SUBCHAPTER 110 - Responsibilities
111 RECRUITMENT OF INTERNATIONAL INSPECTION CADRE MEMBERS
DFI maintains a roster of investigators/ analysts who have been recommended by district management to have demonstrated experience and special expertise in one or more of the following program areas:
Biologics
Bioresearch Monitoring
Biotechnology
Computer Software Development
Drugs - Human and Veterinary
Food/LACF
Medical Devices
Sterile products
The national expert investigators participate in the international inspection program as part of their routine duties. Other investigators/analysts selected to participate in the program have volunteered for temporary duty with the concurrence of district management. As a result, they have made a commitment to be on travel status for an average period of three weeks. All cadre members have shown the ability to work independently, make sound decisions with minimum supervision, and demonstrated the maturity and patience to enable completion of duties diplomatically, in unfamiliar environments while encountering possible language barriers.
All investigators/analysts who believe they meet the above requirements and are interested in joining the international inspection cadre should consult the current FMD 13A International Inspection Program ( Exhibit 1-A ).
112 PLANNING INSPECTION TRIPS
112.1 INSPECTION REQUESTS
International inspections are planned for various reasons. Inspection requests
may come from the Centers. These inspection requests are issued as a result
of:
- Firm is identified in an NDA, ANDA or PMA submission
as a supplier or an alternate of materials, products, or
services.
- Firm submitted a process form for the LACF products
which the Center believes should be evaluated on site.
- Firm has previous violative inspectional history and/or
problems.
- Surveillance inspections of firms which have been identified
using a tiered approach based on factors such as risk,
volume of products, complexity of processes, etc.
- Firms that have problems related to MDRs, adverse reactions,
or were involved in recalls.
In addition, firms that require regulatory or routine coverage
for statutory or other reasons are included for planning future
international inspection trips.
Bioresearch monitoring inspections are conducted at the request
of all five Centers. For BIMO inspections requested by Center
for Drug Evaluation and Research (CDER), it is routine for
a representative from the Division of Scientific Investigations
(DSI) to accompany the investigator during the inspection.
112.2 NUMBER AND TYPES OF FIRMS TO BE INSPECTED
DFI will generally assign several firms to be inspected during
each international trip. Firms selected in a trip will usually
be limited to manufacture one type of product.
The time allotted for each inspection varies depending on
the type and number of products to be covered. Inspections
of firms producing less critical products may be assigned less
time than those making more technically complex items such
as high risk devices or sterile dosage form drugs.
112.3 LENGTH OF TRIP
The average length of an international inspection trip is
three weeks. Occasionally they may be of shorter or longer
durations. If the inspection team finds that additional time
is needed to complete the assignment while on site, they should
notify DFI immediately for modification and/or adjustment of
the itinerary.
Additionally, DFI is to be notified immediately if it appears
that an assigned inspection may be completed sooner than anticipated.
When this occurs, DFI may make adjustments and request that
additional inspectional assignment(s) be conducted.
112.4 TRIP LOCALE
Trip itineraries are developed based on the priority of assignments,
while giving reasonable consideration to geographic locations
of the subject firms. This is sometimes difficult and may necessitate
arduous travel on occasion.
DFI does not routinely schedule inspections in countries that
have an associated State Department travel warning. The State
Department warning is used as a signal that requests for inspection
need to be further evaluated on a case-by-case basis. During
this assessment, FDA weighs concerns about the safety of its
investigators against the health benefits of U.S. public citizens
having access to the product being inspected.
FDA has historically made decisions on the side of caution
for the safety of its investigators. For products that are
an innovative breakthrough or are considered medically necessary,
FDA generally errs on the side of the public health benefit
and will request volunteers to conduct the inspections. FDA
has applied this policy uniformly to avoid establishing precedents
for one country that could not be consistently fulfilled in
other countries for which we have similar travel concerns.
112.5 SELECTION OF INVESTIGATOR/ ANALYSTS
DFI makes all selections of investigators/analysts participating
in international inspections. DFI will select from available
members of the International Cadre those most qualified for
the type of work in specific trips.
112.6 FIRM/AGENT CONTACT
DFI is responsible for making all contacts with the firms
to be inspected as well as their agents. During these contacts,
DFI will arrange for inspection dates, lodging, transportation,
etc.
112.7 DISTRICT CONTACT
At the beginning of planning an international inspection trip,
DFI will contact the home District of the selected investigator/analyst
to determine if he/she can be made available. After obtaining
approval from the DIB, or equivalent management, the investigator
will be contacted directly by DFI regarding the trip. It is
incumbent upon the potential international traveler to inform
DFI of any personal conflicts which would make it difficult
to make the scheduled trip. While continued or multiple trip
rejections may affect future selection, occasional refusal
for valid reasons will have no bearing on further participation
in the program.
112.8 HEADQUARTERS COORDINATION
DFI will coordinate the participation of all Headquarters
personnel.
112.9 LABORATORY COORDINATION
When there is a need for laboratory personnel (usually a Microbiologist
or a Chemist) to participate in an international inspection,
DFI will contact district management and coordinate the corresponding
activities.
113 TRIP FOLDER
DFI will prepare a folder for each inspection trip. A copy
of the information contained in a trip folder will be provided
to the traveler. The folder includes assignments, itinerary,
chronology of contacts with firms or agents, correspondence
with government counterpart authorities, travel orders and
clearance documents, identification of hotels, and any other
pertinent information.
113.1 ITINERARY
The itinerary contains a daily listing of each activity with which the traveler will be involved. The itinerary will start with the day the traveler leaves and will continue until the day the traveler returns. This itinerary will include complete information regarding firm to be inspected, products to be covered, purpose of assignment, and hotel information. The itinerary will also provide the modes of transportation suggested by DFI.
113.2 INTERNATIONAL ASSIGNMENT PLANNERS
DFI will maintain a planner for each firm to be inspected during the inspection
trip. This worksheet will include the reason for the inspection, the names
of contact individuals and
the dates they were contacted, a short summary of each contact,
etc. Telephone numbers
and/or fax numbers for the agents will be provided when available.
Copies of these assignment sheets will be provided to the traveler.
113.3 PASSPORT/VISA
DFI will initiate all paperwork concerning application for official passports
and visas. Fees for visas incurred by the traveler are reimbursable. DFI
will assure that official passports are valid.
The official government passport is U.S. government property
and must be surrendered and kept in a designated secure location
when not in use. The traveler must return the official passport
to DFI as soon as the trip is completed.
113.4 AIRLINE TICKETS
All airline reservations will be made by DFI through a government
contract travel agency.
The travel agency will send tickets directly to the traveler.
Upon receipt, the traveler should verify the flight arrangements
shown on the airline tickets.
The traveler must reconfirm all international flights 72 hours
prior to flight time.
113.5 ADVANCE OF FUNDS
Advance of travel funds should be obtained through the designated
regional payment office for each traveler's district.
113.6 REFERENCE MATERIALS
DFI will locate and assemble all available NDAs, ANDAs, INDs,
DMFs, PMAs, NADAs, etc., for the Investigator/ Analyst. These
documents will be available for review during scheduled briefings.
If a briefing is not planned, the required information will
be mailed to the traveler for review prior to departure. (Original
references should not be carried during travel. Any copies
must be safeguarded).
The travelers must review all necessary records and make appropriate
copies. The travelers must also make desired copies of reference
materials such as USP/NF, Remington's, and Industrial Sterilization,
etc.
114 BRIEFING
International travelers will often be required to come to
headquarters for a briefing prior to departure on the trip.
The briefing generally takes place on Thursday and/or Friday
with departure from the U.S. on Friday afternoon or evening.
DFI will plan and organize these briefings. DFI will assure
that all issues/questions that the Centers want resolved are
known to the traveler. When no formal briefing is conducted,
DFI will provide a written detailed listing of all concerns
of the Centers that must be covered during the inspection.
115 DEBRIEFING
Formal debriefing sessions are not typically planned unless
there are extenuating circumstances. If the international traveler
believes a formal debriefing session is necessary, it should
be discussed with DFI. All other debriefings will be done over
the telephone. Upon return, the international traveler should
inform DFI of the results of all inspections, and any unusual
circumstances that occurred. At this time, the priority of
report preparation should be discussed.
116 TRAINING
DFI will arrange for training courses for the international
inspection cadre members, as necessary, pending available funding.
DFI will
also provide on-the-job orientation to new
international travelers. All new members of the cadre not provided
formal training will accompany an experienced traveler on an
initial orientation trip.
117 NON-INSPECTIONAL REGULATORY TRAVEL
DFI also coordinates all ORA non-inspectional regulatory travel
(e.g., travel to participate in speeches, poster presentations,
etc. and travel funded by the World Health Organization (WHO),
Pan American Health Organization (PAHO), Food and Agriculture
Organization (FAO), Agency for International Development (AID).
When travelers become aware of nomination for such travel,
they must immediately contact DFI. Failure to do so could result
in a delay and/or cancellation of the trip due to no advance
of funds, improper or incomplete travel approval/arrangements,
failure to obtain proper visas and letters of invitation, etc.
Consult FMD 13 International Travel (Exhibit 1-A) for additional
information.
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