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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Inspections

Chapter 1 INTERNATIONAL INSPECTION PROGRAM

Chapter 1 INTERNATIONAL INSPECTION PROGRAM 

Subchapter 100 - GENERAL

 

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:

  1. Firm is identified in an NDA, ANDA or PMA submission as a supplier or an alternate of materials, products, or services.
  2. Firm submitted a process form for the LACF products which the Center believes should be evaluated on site.
  3. Firm has previous violative inspectional history and/or problems.
  4. 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.
  5. 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.