Inspections, Compliance, Enforcement, and Criminal Investigations
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 requirements and procedures to be followed for applying to the International Inspection Cadre and the general expectation for the members. 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/DFI arranges international inspections in the following areas:
- Center Requested Inspections
Centers have primary responsibility for the identification and prioritization of firms for inspection. Many 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. Other assignments, scheduled on a risk basis, include surveillance inspections, directed inspections, and compliance follow-up inspections. Upon completion of the inspection, Centers are responsible for final review and classification of the inspection report along with initiation of indicated action in an efficient manner.
- ORA requested inspections
Based on specific intelligence (e.g. previously violative inspections, entry review, automatic detention, 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
- Oversight of the annual international travel plan/budget in accordance with Staff Manual Guide 2342.1. In preparing the regulatory travel plan/budget, DFI 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)
- Management of the international inspection program to include: trip coordination, review of inspection assignments, arrangement for pre-inspection briefings, evaluation of inspection work products, and monitoring and reporting of accomplishments.
- Liaison with international regulatory authorities and coordination of inspectional activities with the U.S. State Department, DHHS Office of Global Health Affairs, and other FDA components.
- 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.
- Review assignments received from the center to determine what products to be covered, type of inspection and the expertise needed to conduct the inspections.
- Request volunteers from the International Inspection Cadre to conduct foreign inspections and coordinate with the Regional Foreign Inspection Coordination Team (FICT).
- Provide assignments to be conducted by the Foreign Dedicated Cadres and the FDA “Beyond our Borders” Offices through the Dedicated Cadre Supervisors and Office Directors.
- Contact the foreign firm or U.S. agent to describe FDA's reason to conduct an inspection, identify product (s) to be covered and propose the dates of inspection.
- Negotiate and mutually agree on the dates of inspection.
- 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.
- Facilitate obtaining all background information needed from the Center (application information, master files, previous EIRs, etc).
- Prepare all travel authorizations and amendments in GovTrip. Approve all foreign travel vouchers and associated local travel vouchers.
- Coordinate with the Office of International Programs (OIP) to obtain passports/visas for the inspection personnel.
- For specific trips, obtain official passports from OIP for foreign travelers.
- Maintain a list of ORA passport status, in coordination with OIP, and notify International Inspection Cadre (IIC) members and their local management of the need to renew. Notification will be done six months before the passport expiration date. Some countries do not permit travel on passports with less than six months to expiration.
- Process Visa requests for travel to all countries that require a Visa.
- Provide a Notification of Foreign Travel (NFT) to OIP who will seek approval from DHHS and the State Department for the country clearance.
- Coordinate with the Centers when a center employee is part of the inspection team.
- Coordinate with Centers for briefing conference calls with the inspection team, center representatives, OIP, DFI and any other FDA components as needed, both before or after the inspections are conducted.
- Establish contact with foreign regulatory authorities when appropriate to:
- Arrange joint inspections upon their request or at FDA's initiative, or in compliance with any existing agreement with the particular country.
- Arrange for inspectional personnel to meet with foreign counterparts, as needed.
- Assure that the inspection assignments are in FACTS and assigned to the ORA employee(s).
- Provide travelers with relevant information relating to health, personal safety and security as indicated and relevant for the inspection trip.
INTERNATIONAL INSPECTION CADRE (IIC) MEMBER RESPONSIBILITIES
Foreign inspection personnel may be expected to conduct a minimum of one foreign inspection trip every year (members of dedicated cadres are expected to conduct multiple foreign inspection trips per year) and do the following during these international trips:
- 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.
- 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 FOH Clinics or the FOH Network in the local area at no cost to the employee. 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.
- 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 injury or illness.
- Travelers should provide their office management with a copy of the detailed itinerary received from DFI, 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.
- Travelers in countries with State Department Warnings should check in with their DFI Trip Coordinator on a weekly basis. ORA personnel who encounter an emergency situation while traveling abroad should immediately contact the DFI 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 provided to international travelers, if available, so they can be contacted during an emergency.
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.
- Complete inspections according to program and center assignment instructions.
- Promptly after completing the inspection notify the Center and DFI, by fax or by email, of any significant deficiencies which adversely affect the safety of products currently being shipped to the U.S., or where conditions warrant immediate Center attention. A form is provided for this purpose and should be accompanied by the FDA 483 if issued.
- Meet with counterparts in foreign regulatory agencies to discuss inspectional findings, FDA 483s, and general inspection matters, as directed by DFI
- Efficiently complete the Establishment Inspection Report (EIR) and inspection disposition.
- Information reported to DFI will be forwarded to the appropriate center by DFI, if not done by the investigator.
- The investigator must submit the EIR in a timely manner commensurate with the District Recommendation enforcement action anticipated 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.
- All completed EIRs will be promptly forwarded to appropriate center offices based on procedures in FMD 86 and routing instructions provided by DFI with the inspection preparation materials.
- The endorsing manager will enter the appropriate inspection classification and District Decision code, in a timely manner, and notify the investigator of the final classification. Centers are expected to review the coversheets and EIR to determine the final District decision so as to process regulatory actions in a timely and effective manner. Centers will also assure that the profile status correlates with the Final District Decision.
- Inspections resulting in official action or requiring significant voluntary corrective action will be rescheduled, by DFI, for follow-up with the concurrence of the center and/or in accordance with current procedures.
- Prepare a proposed endorsement with an inspection conclusion and a district decision under the provisions of FMD 86.
- Complete FACTS profile screens for each drug, device, or biologics (except blood and plasmapheresis) facility inspected.
- 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.
- 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 DFI.
- Ensure the inspections are reported into FACTS in a timely manner (within 30 working days from the end of the inspection).
A more detailed description of the responsibilities of inspection personnel is described in the current Guide to International Inspections and Travel (GIIT).
THE INTERNATIONAL INSPECTION CADRE
DFI maintains a roster of the International Inspection Cadre (IIC). The IIC currently consists of ORA field, HQ and Center personnel (investigators, compliance officers, chemists and microbiologists) who have demonstrated inspectional experience and expertise in one or more of the following program areas: food safety, outbreak investigations, CGMP (drugs), antibiotics, sterile products, Quality System Regulations (devices), LACF, MQSA, CGMP (biologics), and clinical and non-clinical bioresearch monitoring inspections.
National expert investigators and members of Team Biologics conduct international inspections, participate in international conferences and seminars as part of their duties and are part of the Cadre.
In addition to requiring programmatic experience and expertise to effectively represent the FDA and the United States, international inspection work is challenging in other ways. It requires: sound decision making with minimal supervision; professionalism and diplomacy; efficiency, flexibility, and adaptability.
ORA field management will assure that all of their qualified investigators and analysts GS-12 and above become part of the IIC. If field management feels that an employee is not qualified, they will work with the employee to develop the necessary skills to qualify.
Note: If field management is confident that a GS-11 employee meets the experience and skill requirements, they will assure they become part of the IIC.
- Qualified individuals will submit an Application for the International Inspection Cadre (Attachment A), to their management. Emphasis should be placed on providing information on the employee's investigational experience and specific skills. Field management will review all applications and certify the employee meets the criteria for nomination as per Attachment B. Applications can be submitted to the Director, International Operations Branch/DFI with field management concurrence at any time.
- Send Applications by e-mail or fax to:
Director, International Operations Branch/DFI (HFC-130)
FDA/5600 Fishers Lane, Rm.16-70, Rockville, MD 20857
- All employees GS-11 and above who are deemed to be qualified by field management to conduct International Inspections will apply for an Official Passport.
- Investigators are generally assigned international trips after taking the Orientation to International Inspection Web Modules and webcast. If needed, they can be accompanied by an experienced investigator on their first trip.
- The Director, International Operations Branch, will notify local management if a traveler has not demonstrated the required experience and expertise listed in the above section, inspection reports are not submitted in a timely manner, or for other pertinent reasons.
International inspection cadre members are expected to take at least one trip per fiscal year. Members may request through their management, withdrawal from the program should circumstances preclude continued international travel.
The Nomination and the Criteria Required for Nomination to the FDA International Inspection Cadre are Attachment A and B, respectively.
|Distribution:||Regional Food and Drug Directors, District Directors, and FDA Headquarters Offices|
|FDA Headquarters Offices|
|Issued by:||ORA/ORO/Division of Field Investigations (HFC-130)|
|Publication Date:||March 2009|