Inspections, Compliance, Enforcement, and Criminal Investigations
Foreign Inspection Program
Foreign Inspection Program
October 05, 2010
ORA FIELD MANAGEMENT DIRECTIVE No. 13A
This Field Management Directive (FMD 13A) describes the role and responsibility of ORA in international inspection activities. It includes the procedure for planning and scheduling international inspections, reporting results of inspectional findings, and classifying Establishment Inspection Reports (EIRs). It also outlines the qualifications and capabilities of FDA personnel who will be expected to lead or participate in international inspection activities. Refer to FMD 13 regarding development, administration, and execution of the international travel plan and procedures for international travel requests.
FDA has conducted international inspections since 1955. Over the years, international inspections have increased in both complexity and frequency and cover all products subject to regulation by FDA. The inspection interval and depth of coverage of inspections are consistent with the periodic inspections of FDA's domestic program insofar as practical. Currently, without statutory authority to authorize FDA inspections, inspections are planned in advance with the foreign firm consenting to FDA inspection. If a firm fails to consent to inspection, FDA considers its options with regard to product approval and entry admissibility decisions.
ORO/DFFI arranges international inspections in the following areas:
1. Center Requested Inspections
Centers have primary responsibility for the identification and prioritization of firms for inspection. Many medical products foreign inspections are application-driven preapproval inspections and are conducted when inspection information on a specific firm and/or process is needed but the available information is inadequate, not current, or nonexistent. Assignments in the preapproval context also include inspection activities associated with the bioresearch monitoring program. Other assignments, scheduled on a risk basis, include surveillance inspections, directed inspections, and compliance follow-up inspections. Upon completion of the inspection, ORA typically makes an initial classification recommendation, Centers are responsible for final review and classification of the inspection report along with initiation of indicated action in an efficient manner, with communication and action expedited for situations that may represent immediate public health impact.
2. ORA Requested Inspections
Based on specific intelligence (e.g. previously violative inspections, entry review, detention without physical examination, product recall) and in consideration of general Center priorities, ORA may initiate foreign inspection planning to support the overall international inspection program operations and performance expectations.
ORA HEADQUARTERS RESPONSIBILITIES AND PROCEDURES
1. Oversight of the annual international travel plan/budget in accordance with Staff Manual Guide 2342.1. In preparing the regulatory travel plan/budget, DFFI will also consider ORA non-regulatory international activities on a case-by-case basis (e.g. participation in: scientific conferences, counterpart government meetings, international organization meetings or conferences).
2. Management of the international inspection program to include: trip coordination, review of inspection assignments, arrangement for pre-inspection briefings, evaluation/endorsement of inspection work products when done by DFFI staff, monitoring and advocacy in OAI situations and reporting of accomplishments.
3. Management and direction of dedicated international inspection cadres.
4. Liaison with OIP and international regulatory authorities and coordination of all FDA inspectional activities with the U.S. State Department, DHHS Office of Global Health Affairs, and other FDA components including FDA staff stationed in a foreign country.
5. Arrangement of emergency or other special international trips to: investigate outbreaks of food borne illness, collect evidence required in case development, attend urgent meetings with foreign government and industry officials for problem solving, and conduct surveys.
6. Cell phones, blackberries with cell phone capability, or calling cards (for countries that don’t support FDA’s cell phones) will be available to every traveler and/or at least one member of an inspection team and will be provided by either DFFI or by the district, as part of a cell phone/blackberry program.
1. Review assignments received from the center to determine products to be covered, type of inspection and the expertise needed to conduct the inspections.
2. Seek qualified personnel to conduct foreign inspections and coordinate with the Regional Offices.
3. Issue assignments directly to DFFI’s dedicated international inspection cadre(s) and to FDA staff stationed in a foreign country through the FDA Country Director or their designee.
4. Contact the foreign firm or U.S. agent to describe FDA's intent to conduct an inspection, identify product(s) to be covered and propose the targeted dates of inspection which then may be negotiated to reach mutual agreement.
5. Prepare trip schedules and arrange lodging and transportation for the investigator or the inspection team. Provide a Travel Packet inclusive of all documentation and related information to the traveler.
6. Facilitate obtaining all background information needed from the Center (application information, master files, previous EIRs, etc) with sufficient lead time for the investigator or the inspection team. Assignments received by DFFI will be sent to the CSO within 48 hours after the CSO is assigned to the trip.
7. Prepare all travel authorizations and amendments in GovTrip. Review and approve foreign travel vouchers and associated local travel vouchers.
8. Coordinate with the Office of International Programs (OIP) to obtain passports/visas for the qualified inspection personnel.
a. For specific trips, obtain official passports from OIP for foreign travelers.
b. Maintain a list of ORA passport status, in coordination with OIP, and notify foreign travelers and their local management of the need to renew. Notification will be done one year before the passport expiration date. Some countries do not permit travel on passports with less than six months to expiration.
c. Process visa requests for travel to all countries that require a visa.
9. Provide a Notification of Foreign Travel (NFT) to OIP who will seek approval from DHHS and the State Department for the country clearance.
10. Coordinate with the Centers when a center employee is a necessary part of the inspection team.
11. Coordinate with Centers for pre-inspection conference calls with the inspection team, center representatives, OIP, DFFI and any other FDA components as needed and arrange for debriefs, as needed, when the inspections are concluded.
12. Establish contact with foreign regulatory authorities when appropriate to:
a. Arrange joint inspections upon their request or at FDA's initiative, or in compliance with any existing agreement with the particular country.
b. Arrange for inspectional personnel to meet with foreign counterparts, as needed.
13. Assure that the inspection assignments are in FACTS and assigned to the ORA employee(s).
14. Provide travelers with relevant information relating to health, personal safety and security as indicated and relevant for the inspection trip.
15. Establish an inspection feedback mechanism, in a quality systems framework, to solicit information, review, analyze, and initiate process improvements when indicated.
INTERNATIONAL TRAVELERS RESPONSIBILITIES
Qualified ORA Investigators and Analysts may be expected to conduct a minimum of one international inspection trip every year (members of dedicated cadres are expected to focus all inspection work in the international arena and therefore will conduct multiple inspection trips per year) and are responsible for the following during these international trips:
1. Traveler HEALTH, PERSONAL SAFETY, AND SECURITY are of paramount importance to FDA. The agency’s policies and procedures support the health, personal safety and security of travelers but travelers themselves are encouraged to make every effort to ensure their health, safety and security while in international travel status.
a. Travelers should refer to the CDC Website for the required and/or recommended vaccinations/medications for the country to be visited. Requests for Hepatitis A, Hepatitis B and travel immunizations can be made to Federal Occupational Health (FOH) Clinics or the FOH Network in the local area at no cost to the employee, see FOH directory at: http://www.foh.dhhs.gov/Whereweare/directory.asp. If the employee decides to go privately, the agency will only reimburse the cost of any required vaccinations or medications and not those that are just recommended.
b. Prior to departure, travelers should verify with their private medical insurance providers as to what services and coverage they will have in case they become ill or injured while on business in a foreign country. The FDA does not provide separate medical insurance or reimbursement for medical treatment needed while on foreign travel. All employees on official business abroad are covered by the Federal Employees Workmen’s Compensation Act for any work related injury or illness.
c. Travelers should provide their office management with a copy of the detailed itinerary received from DFFI, so that they can be contacted in an emergency. All travelers are required to electronically register with the US Embassy in the country they are traveling to, according to the instructions provided in their itinerary.
d. Travelers in countries with State Department Warnings should check in with their DFFI Trip Coordinator on a weekly basis. ORA personnel who encounter an emergency situation while traveling abroad should immediately contact the DFFI personnel provided in their itinerary first or FDA/ORA’s Prior Notice Center at 1-866-521-2297 or 703-621-7783. International cell phones will be available to every traveler and/or at least one member of an inspection team and will be provided by either DFFI or by the district, as part of a cell phone/blackberry program.
The following web sites will provide useful information for the international traveler.
- Centers for Disease Control
Information on diseases in specific countries, inoculations and prevention measures.
- CIA Fact Book
Information on climate, population, political parties, and the economy for all countries.
- State Department Travel Warnings and Alerts
The site has information on more than 160 countries. It describes entry requirements, travel conditions, available medical facilities, areas of instability and more.
2. Complete inspection activities according to program and center or ORA assignment instructions. CSOs assigned to conduct foreign inspections are expected to be able to inspect and apply the regulations to all operations to be covered during inspections, including laboratory related operations. Analysts can be requested to support assignments for multiple complex assignments, sterile drug inspections, bioequivalence inspections that have a laboratory component, or if directed in the assignment. Within 2 days of receipt and review of the inspection assignment documents if a CSO determines that an Analyst is required on the inspection a written request should be sent through the CSO’s Supervisor to DFFI and to the ORA regional office. If approved, the request for an analyst will be processed.
3. If conditions are observed during the course of inspections that raise immediate concern with regard to the safety, effectiveness, or quality of products distributed to the U.S., immediately notify the respective Center and DFFI, by fax or by email. Additionally, if inspections may result in an initial OAI classification, upon conclusion of the inspection, notify the respective Center and DFFI by fax or by email of any significant deficiencies and provide a copy of the FDA 483 (if issued).
4. Meet with counterparts in foreign regulatory agencies to discuss inspectional findings, FDA 483s, and general inspection matters, as directed by DFFI.
5. Efficiently complete the Establishment Inspection Report (EIR) and initial inspection classification in consultation as needed with DFFI staff or home district supervisor.
a. Inspectional information reported to DFFI will be forwarded to the appropriate center by DFFI, if not done by the investigator.
b. The investigator must submit the EIR in a timely manner commensurate with the initial classification (and any recommended enforcement action) but not to exceed 30 working days from the return of the investigator from the trip. All EIRs are to be completed in TURBO EIR; it is recommended, but not required, to complete all FDA 483s in TURBO EIR.
c. All completed EIRs will be promptly forwarded to appropriate Center offices based on procedures in FMD 86 and routing instructions provided by DFFI with the inspection preparation materials.
d. Investigators are responsible for preparing the recommended District initial classification following the guidelines of FMD 86. District management may at their discretion review the prepared endorsement prior to submission to the Center. Centers are expected to support any interim actions needed to protect public health and to review the coversheets and EIR to determine the final inspection classification (i.e. final District Decision) in a timely and effective manner. Centers will also assure that the profile status correlates with the Final District Decision. Centers should notify DFFI and foreign travelers of the final classification and provide any appropriate inspection feedback through established processes.
e. Inspections resulting in official action or requiring significant voluntary corrective action will be rescheduled, by DFFI, for follow-up with the concurrence of the Center in accordance with current procedures.
6. Ensure the inspections are reported into FACTS in a timely manner (within 30 working days from the end of the inspection). Complete FACTS profile screens for each drug, device, or biologics (except blood and plasmapheresis) facility inspected, and submit the international inspection feedback form.
7. Upon return, contact their Trip Coordinator to discuss if an amendment is needed to the travel authorization prior to submitting a Travel Voucher. For example, an amendment will always be needed for any actual lodging costs going over the allowed per diem costs, changes in itineraries such as change of cities or extended dates of travel. A form is provided for this by the Trip Coordinator with their inspection preparation materials.
8. Prepare and submit a Travel Voucher in the agency’s electronic travel system within five days of the traveler’s return according to the instructions provided in the travel packet. Promptly return official passport, international cell phone, or any other borrowed inspectional equipment or preparation materials to DFFI.
9. A more detailed description of the responsibilities of inspection personnel is described in the current Guide to International Inspections and Travel (GIIT).
QUALIFIED INTERNATIONAL INSPECTION PERSONNEL
Each Region will maintain a current, accurate list of qualified international inspection personnel, their areas of expertise/specialization/certification level, and ensure they all have current, official passports. The list will include all qualified investigators and analysts (to lend their expertise to the inspection activities in support of the overall international inspection program). The list will be updated as needed and will be provided, or made accessible, to DFFI who will maintain a master Agency list that includes the regional lists in addition to qualified ORAHQ and Center personnel who also support the international inspection program.
Attachment B describes the qualifications the need to be considered for international inspection personnel that conduct international inspections.
ORA field and headquarters managers will assure that all of their qualified investigators and analysts are properly accounted for on the regional and master list. Upon investigators and analysts reaching the grade level, programmatic and professional expertise to be deemed qualified to conduct international inspections (refer to Attachment B), they will be notified and listed on the regional and master lists. Once listed, they may be assigned international inspection work which will require that they obtain an official government passport to conduct such work, and complete the Orientation to International Inspection Web Modules and webcast. If needed, they can be accompanied by an experienced investigator on their first trip.
If otherwise qualified investigators or analysts are unable to travel internationally due to a medical condition that cannot be accommodated through exceptions to government travel requirements (e.g. business class airline accommodations as a medical accommodation), district or division managers (consulting with FOH physicians or otherwise) may consider them “medically not qualified” for the purpose of international inspection activities on either a short term or a long term basis. At the same time, district or division management may consider accommodations or other arrangements to support continued conduct of domestic inspection activities. To assist in uniformity of such accommodation decisions and the designation of a person as “medically not qualified” for international travel, Guiding Principles can be found at Attachment A to this FMD (13A).
Some qualified investigators or analysts who are assigned inspection activities in an international setting, may experience personal difficulty due to a unique personal situation. In those situations when known by management - which may require accommodations for child care, traveling spouse, elder care, etc - DFFI will make every effort to schedule trips with as much advance notice as possible and will attempt to limit foreign inspection trips to two weeks in duration, rather than the customary and more efficient three week trip.
Distribution: Regional Food and Drug Directors, District Directors, and FDA Headquarters Offices
Issued by: ORA/ORO/Division of Field Investigations (HFC-130)
Publication Date: September 2009