Field Management Directive 130

• PURPOSE
• BACKGROUND
• RESPONSIBILITIES AND AVENUES OF COMMUNICATION
  • OFFICE OF REGULATORY AFFAIRS (ORA)
    • ORA Headquarters
      • Division of Planning, Evaluation and Management (DPEM) HFC-40, Program
      • Planning and Workforce Management Branch, (PPWMB) HFC-41
      • Office of Information Technology – ORA (OIT), HFC-30
      • Division of Field Investigations (DFI), HFC-130
      • Division of Import Operations and Policy (DIOP), HFC-170
      • Division of Compliance Information and Quality Assurance (DCIQA), HFC-240
    • ORA District Offices
  • CENTER RESPONSIBILITIES
• DEFINITIONS
• Firms Database
• Official Establishment Inventory (OEI)
  • Workload Obligation Establishments
  • Non-workload Obligation Establishments
  • Potential Firms
  • Potential Bioterrorism Firms
• Establishment
• Establishment Types
• Industry/Product Code
• Firm Establishment Identifier (FEI)/Central File Number (CFN)
• DATABASE DESIGN, USER ROLES
• GENERAL RULES AND GUIDANCE FOR OEI MAINTENANCE
• Appendix I - Content Structure of the OEI and Data Entry Screens
• Appendix II -Guidance for Coding Establishments on Firm’s File as Workload Obligation
  • Equal to Yes or Workload Obligations Equal to No by Establishment Type
• Appendix III - Guidance for Coding Establishments on Firm’s File as Workload
  • Obligation Equal to Yes or Workload Obligations Equal to No by Industry Code
• Appendix IV - General Rules and Guidance for Assignment of Firm Establishment
  • Identifiers
• Appendix V - Establishment Types
• Appendix VI - Industry Codes

PURPOSE

The purpose of this Field Management Directive is to provide guidance for uniform, accurate, and complete Official Establishment Inventory (OEI) development and maintenance by providing:

• A standard definition of what should and should not be in the OEI.
• Standard procedures to be followed to assure the OEI is accurate and complete.
• A summary of field, headquarters, and centers responsibilities for ensuring consistency in OEI maintenance and development.
• Integration of the OEI into the firms module within Field Activities Compliance Tracking System (FACTS), an FDA assignment driven computer system for monitoring activities conducted by FDA field, headquarters, and center offices at FDA regulated firms.

The Agency depends on the accuracy, completeness, and uniformity of the OEI data. FDA uses the information from the OEI to provide Congress, other government agencies, and the public with the type and number of regulated establishments. The data from the OEI is also utilized for budget presentations to justify resources received and to request additional resources to accomplish FDA’s obligations under the Federal Food, Drug, and Cosmetic Act(FD&C) and other related Acts.

The allocation of resources to each district is driven by the OEI. The Division of Planning, Evaluation and Management (DPEM), HFC-40, as well as the Centers, use the OEI to allocate resources for the compliance programs and assignments which are identified in the annual field workplan. These obligations ultimately determine each district's staffing and are used by the field to plan their inspections as well as other enforcement activities.

The Office of Regulatory Affairs (ORA) headquarters, ORA field offices, and the Centers have recognized the need for standardized definitions, data consistency in the OEI, and uniform maintenance and development of procedures. This Field Management Directive (FMD) provides this guidance. The last update of this FMD was 05/16/97.

BACKGROUND

In 1961, instructions were issued to all field offices on the assignment of Central File Numbers (CFNs) to establishments as they were inspected. This guidance was the beginning of the OEI, as we know it today. Since then there have been many changes within the Agency, which have led to a revision of instructions on the assignment of CFNs and adjustments to the definitions of establishments and of CFNs.

In FY 1981, a thorough review of the OEI was conducted by the field. The establishments never inspected or not inspected in the last five years were identified. Incomplete/incorrect codes (i.e., establishment types, industry codes, etc.) were also corrected for the uninspected establishments and zip codes and telephone numbers were added for those establishments remaining in the active OEI. To facilitate manipulation of the OEI and reduce computer costs, an auxiliary OEI file was established to contain information about Out of Business (OOB) and Not-OEI Establishments (NOE). Subsequently, this file was expanded to include establishments not essential to district workplanning/scheduling, or not needing to be routinely included in the active OEI file.

In July 1993 via a Field Guidance memorandum, the Center for Drug Evaluation and Research (CDER) reclassified establishments which manufacture or manipulate compressed or liquefied medical gases from repackers to manufacturers.

In FY 1994, the Center for Biologics Evaluation and Research (CBER)transferred the inspectional responsibility for Military Blood Banks (Domestic and Foreign) to ORA.

Mammography facilities were added to the OEI in FY 1995. The Mammography Quality Standards Act (MQSA) of 1992 established the authority for the regulation of mammography services and radiological equipment.

In early FY 1997, ten new establishment type definitions and ten two-character establishment type codes were implemented. A new establishment type, entry filer (EF), was added and the current importer/broker establishment type was modified to accommodate the Operational and Administrative System for Import Support (OASIS).

Between 1996 and 2000, development and implementation of FACTS occurred. This was areplacement system for the Field Information System (FIS) used by the Agency for many years. The OEI formerly resided within FIS. Prior to the development of the system, a series of Joint Application Design (JAD) meetings were held to discuss business requirements and to expedite conversion of OEI data from FIS to FACTS between FDA centers, field and headquarters, and the contractor Booz-Allen Hamilton.

Data about firms can be entered directly into FACTS on data entry screens or indirectly through the OASIS system. Both FACTS and OASIS automatically generate a Firm Establishment Identifier (FEI) number which is a ten digit number that replaced the seven digit CFN. The old CFN number is still retained and can be viewed through the cross-reference screen.

Under FIS, each district had their own OEI database (both active and auxiliary) stored on their local system. Monthly updates were consolidated into a single headquarters active and auxiliary file. Under FACTS, the system is a national relational database which contains the most current information at all times. Firms previously in the active file are coded workload obligation = “yes” and firms previously in the auxiliary file are coded workload obligation = “no”. Under FIS, the OEI database contained only domestic firms. With the implementation of FACTS, the Division of Field Investigation’s (DFI) TRIPS database was loaded into the firm file in FACTS allowing access to foreign firm data.

RESPONSIBILITIES AND AVENUES OF COMMUNICATION

1. OFFICE OF REGULATORY AFFAIRS (ORA)

   1. ORA Headquarters

      1. Division of Planning, Evaluation and Management (DPEM) HFC-40, Program Planning and Workforce Management Branch, (PPWMB) HFC-41

         Contact: Office of Resource Management, Division of Planning, Evaluation and Management (DPEM) Program Planning and Workforce Management Branch (PPWMB) – Michael W. Roosevelt, Director (301) 827-1638

         PPWMB is responsible for establishing the criteria for including establishments in the OEI, providing definitions and guidance to the field offices, and acting as liaison between the field offices and the centers.

         PPWMB may periodically send Districts a list of firms by workplan project for review. Districts may use this as a guide and compare to their lists. If there are any discrepancies, it will be the responsibility of each District to make the necessary changes.

      2. Office of Information Technology – ORA (OIT), HFC-30

         Contact: Office of Management, Office of Chief Information Office, Office of Information Technology – ORA, Business Information Staff: George Brush, Chief (301) 827-6709; Allen Goldberg, OEI Application: (301) 827-1554

         OIT will furnish technical assistance and systems analysis support to the districts regarding data processing problems or needs and instructions for data entry and data access.

      3. Division of Field Investigations (DFI), HFC-130

         Contact: Office of Regional Operations, Division of Field Investigations – Michael Rogers, Director (301) 827-5653.

         DFI will be responsible for maintaining a List of District OEI Coordinators in the Investigations Operations Manual (IOM).

         DFI will act as liaison between the district offices and the Centers in all matters pertaining to registration policy as set forth in Field Management Directive No. 92.

         DFI is responsible for management of foreign OEI.

      4. Division of Import Operations and Policy (DIOP), HFC-170

         Contact: Office of Regional Operations, Division of Import Operations and Policy, Systems Branch – Steve Kendall, Director (301) 594-1162

         DIOP is currently responsible for OASIS. OASIS is an automated FDA system for processing and making admissibility determinations for shipments of FDA regulated products of foreign origin seeking to enter domestic commerce. Firm data from OASIS is integrated into FACTS.

      5. Division of Compliance Information and Quality Assurance (DCIQA), HFC-240

         Contact: Office of Enforcement, Division of Compliance Information and Quality Assurance – David Gallant, Director (240) 632-6812

         DCIQA is responsible for communication between the field and Centers on information and issues related to firm profiles.

   
   

   2. ORA District Offices

      1. Districts are responsible for:

         1. The accuracy and completeness of their OEI (establishments in the firm’s file) within their geographical territory.

         2. Appointing a district OEI coordinator/contact person who has knowledge of the OEI/FACTS. This person is the liaison to the DPEM/PPWMB on district OEI projects. The name of each district’s OEI contact should be furnished to DPEM and DFI.

         3. The identification and verification of prospective new establishments toinclude as a workload obligation in the OEI. This is accomplished through the use of telephone calls, visits, information obtained from local or stateagencies, or any other appropriate means selected by the District. Documentation of the addition of an establishment to the OEI can be accomplished by the completion of Form FDA 457, Product/Establishment Surveillance Report (http://intranet.fda.gov/omp/forms/internal/FDA-457.PDF).

         4. The initial input of data about firms into FACTS through use of firm search and build screens other than automated features such as OASIS and BT Food Registration. The district OEI coordinator is responsible for merging duplicate firms in FACTS (See Appendix IV for general rules and guidance on the assignments of firm establishment identifiers).

         5. Ensuring Federal and State investigators verify, correct, and enter changes to the OEI on the firm’s maintenance screens in FACTS during each inspection. Asupervisor’s review/endorsement of inspections/sample collections, etc. should include a review of the firm's data within FACTS. Any visible inaccuracies or inconsistencies should be brought to the attention of the investigator for verification/correction of the data. This information includes:

            1. Establishment Name
            2. Address including Zip Code
            3. Telephone number
            4. JD/TA
            5. County
            6. Registration Information
            7. Size
            8. Establishment type(s) and related Industry code(s)
            9. Percent (%) Interstate
            10. Percent (%) Wholesale (Food codes only)
         
         
         6. Updating/canceling data on registration screens in FACTS and communicating information between the centers. This activity can only be accomplished by a person with the district registration monitor role in FACTS. Refer to sections under registration in this FMD and FMD 92 for specific guidance



2. CENTER RESPONSIBILITIES

   1. Each center should have a designated OEI coordinator who is also the OEI contact person and is responsible for identifying center OEI needs and deficiencies to PPWMB. Centers may also submit any requests for verification of OEI data to the districts and/or PPWMB. The centers should submit their OEI coordinator name and telephone number to the districts and PPWMB. See "Registration Issues" under "General Rules and Guidance" section.

   2. Centers have the responsibility of receiving registration data for their industries, and forwarding the information to the appropriate district offices for entry into FACTS. Centers should refer to FMD 92, Agency Establishment Registration and Control Procedures, and contact DFI on all registration issues.

DEFINITIONS

1. Firms Database

   The firms database contains information related to FDA regulated firms, both domestic and foreign, and other entities encountered during the course of doing business. Domestic includes any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico. An establishment is a separate type of firm that processes, manufacturers, labels, repacks, stores, distributes, tests or otherwise manipulates products, or performs services that are regulated by the FDA.

2. Official Establishment Inventory (OEI)

   The OEI, which resides within the firms module in the FACTS database, contains information on establishments whose activities are identified as being within the jurisdiction of the Food and Drug Administration.

   1. Workload Obligation Establishments

      In general, the firms identified as workload obligation = “yes” will consist of:

      1. All registered biologics, drugs, animal drug, and device establishments. Most food firms registered under the BT Act.

      2. All establishments which FDA is required by statute to inspect within a specified time period (e.g., drug manufacturers).

      3. All establishments that FDA inspects on a recurring cycle not pre-determined by statute (e.g., Bioresearch Monitoring (BIMO) establishments such as Clinical Investigators). See Appendix II Remarks for specific instructions. BIMO firms are reclassified to workload obligation = “no” after a specific number of years of inactivity depending on establishment type.

      4. Other selected establishments, which are, by statute, subject to FDA regulations, but are not inspected on a recurring basis per FDA discretion (e.g., Class I devices).

      5. Establishments involved in seasonal activities, such as small maple syrup manufacturers, which operate only in the spring. Seasonal establishments remain as workload obligation = “yes” in the firm file.

      6. Inactive establishments which are temporarily not in operation but are expected to resume operations (e.g. a firm undergoing renovation or repair due to storm damage or other catastrophic event). Inactive establishments remain as workload obligation = “yes” in the firm file.

      7. Non-workload obligation establishments against which the Agency is actively pursuing a regulatory action or on-going investigation to assist states or other agencies. When these exceptions occur, a change from workload obligation = “yes” to workload obligation = “no” must be completedafter FDA activity has been completed.

      8. Pre-production firms that will process FDA regulated products in the near future.

         Note: DPEM recommends that the inspection reschedule date from the date of last inspection not exceed five years for firms with workload obligation = “yes”. New firms with workload obligation = “yes” should be inspected within two years of the add date to the Firm File.

   
   

   2. Non-workload Obligation Establishments

      In general, firms identified as workload obligation = “no” will consist of:

      1. Out of Business establishments (OOB). A firm that is no longer in business for reasons other than having moved.

      2. Not Official Establishment Inventory (NOE) establishments. NOE establishments are those that no longer engage in activities or manipulate products subject to FDA regulation, but still remain in business.

      3. Establishments that have previously been workload obligations but are no longer classified as such due to Agency resource constraints, low inspectional priority status, or are no longer inspected by FDA (e.g., methadone clinics).

      4. OASIS/NEC (OAS) establishments. These are establishments that are automatically entered into the firms database through OASIS as a result of import entries. These may be duplicate entries of existing firms in the OEI.

      Rules and guidance for coding establishments as workload obligation = “yes” or workload obligation = “no” appear in Appendices I and II.

   3. Potential Firms

      Potential is an interim classification that flags a firm for further review by the OEI coordinator. The establishment types and industry codes must be entered when the workload obligation flag is changed to “yes”. Many of these firms are added to the firm file by OASIS.

   4. Potential Bioterrorism Firms

      Potential Bioterrorism is an interim classification that flags a firm for further review by the OEI coordinator. This is the workload obligation status assigned to a firm when the firm record is automatically entered into the firms database by the FDA Unified Registration and Listing System (FURLS) as a result of food facility registrations submitted via the Food Facility Registration Module (FFRM) within FURLS. Food facilities are required to register per the Bioterrorism Act of 2002.This record may be incomplete and may be a duplicate of an existing operational firm in the OEI.




3. Establishment

   An establishment is a business or other entity under one owner and at one geographic location or address that handles products or performs activities subject to FDA jurisdiction. Any individual, or group of individuals, whose activities fall under the jurisdiction of the FDA and for which an establishment type is defined, is considered to be an establishment.

   1. The activities at one establishment may be in more than one product or program area and thus the responsibility of more than one center.

   2. "One geographic location or address" is to be reasonably construed to include separate buildings within close proximity if the activities in them are closely related to the same business enterprise, under the supervision of the same local management, and are capable of being inspected at the same time.

   3. Two or more business enterprises (separate legal entities) with different management, although using the same facility or the same address, are to be identified as separate establishments. See Appendix IV, General Rules and Guidance for Assignment of Establishment Firm Identifiers, for additional instructions.

   Do not issue separate FEIs for a firm simply because the firm requests them.

4. Establishment Types

   Establishment types identify the activity(s) accomplished by or at an establishment of interest to the FDA. Establishment type definitions are delineated in Appendix V, Establishment Types.

5. Industry/Product Code

   The industry code is the first two-digits of the seven-character product code which describes a broad category of products regulated by FDA. For the purposes of the OEI, the industry code(s) associated with each establishment represents the final or finished product(s) of that establishment, not components of the final product(s). Industry codes and the product groups they represent are identified in Appendix VI, Industry Codes.

6. Firm Establishment Identifier (FEI)

   FACTS automatically generates a 10-digit FEI number under the firm build screen when a new firm is added. Firms previously in FIS retained their original 7-digit CFN which, in most cases, also became their FEI number. The old CFN can be viewed under the cross-reference viewing screen in FACTS. See Appendix IV, General Rules and Guidance for Assignment of Firm Establishment Identifiers, for assignment rules of FEI numbers.

DATABASE DESIGN, USER ROLES

The firm data in the OEI is stored in a series of tables in a relational database within the Firms module in FACTS. Knowledge of tables, interrelationship of tables within the firms system, columns with tables, and lists of values associated with columns are essential for data queries of multiple records using SQL, IQ solutions, or Business Objects.

Although FDA has not developed a user manual for FACTS, training courses are offered in addition to the Investigations Operations Manual (IOM) which provides additional information and instructions. FACTS on line help screens should be the first source of information for any FACTS related question. If additional help is necessary, users should contact their local FACTS Cadre lead users.

In order to ensure consistency and maintain data integrity, specific user roles have been assigned for making changes and entering OEI or registration data. The two roles are the District Office OEI Coordinator (DO_OEI_COOR) and the District Office Registration Monitor(DO_REG_MNTR).

GENERAL RULES AND GUIDANCE FOR OEI MAINTENANCE

The following guidelines are general in nature and should only be used as such. There may be situations where, in order to describe the activities of an establishment accurately, codes must be assigned contrary to these guidelines. If this occurs, please document the circumstances and solution in the Establishment File jacket. For specific guidance on coding establishments as workload obligation, see Appendix II (by Establishment Type) and Appendix III (by Industry Code). For specific guidance on the content structure of the OEI and the FACTS screens used for data entry, see Appendix I.

1. Only code establishments that receive or ship in interstate commerce raw materials or finished products directly or indirectly as workload obligation = “yes”. There are several types of establishments regulated by FDA that do not necessarily deal in interstate commerce, such as Blood Banks, Bioresearch Monitoring establishments, MQSA facilities, etc, see Appendix II for specific workload obligation requirements for the different establishment types.

2. Many establishments perform operations or produce products which do not meet the criteria for inclusion as a workload obligation in the OEI. However, as long as an establishment is involved in producing at least one product qualifying the establishment as a workload obligation in the OEI, that establishment should remain as a workload obligation = “yes”, even though it may produce products that are not a workload obligation.

3. Activities accomplished by an establishment may meet the definition for more than one establishment type. For example, an establishment may manufacture one product and repack another manufacturer's product. In this event, the establishment should have both (M) manufacturer and (R) repacker establishment types. If an establishment stores finished products manufactured by other establishments, it is correct to add the appropriate warehouse establishment type (WA, WR, WF, or WZ) to the establishment’s list of establishment types. However, if the establishment stores their own finished products, the establishment should be identified in the OEI as a manufacturer and repacker only since the warehousing activity is part of that establishment's normal business operations. A distribution center not located at the manufacturing site would be a separate establishment and coded with the appropriate warehouse establishment type – WA, WZ, WR, or WF.

4. Industry codes in the OEI record must represent finished products which are the responsibility of that establishment. This does not include conveyances inspected on premises. When inspecting products in process, raw materials or ingredients such as vitamins, food/color additives, enter only finished product industry codes in the data entry screen in FACTS.

5. Coding New Establishments as Workload Obligation in the OEI File

   Establishments to be coded as workload obligation on the Maintain Firms screen in FACTS may be discovered in a variety of ways. Some of these are:

   1. Surveillance on the part of district personnel (observation while traveling, ads, state government directories, newspaper financial pages, trade publications).

   2. Newly registered establishments.

   3. Violative domestic sample collected which was ultimately found to be from an establishment with no FEI.

   4. Referred by state, other agency, or other FDA office.

   5. Special assignments and surveys which require the inspection of establishments not regularly maintained as workload obligations in the OEI file.

      Do not enter an establishment (firm build) in the OEI (generate a FEI Number) as workload obligation = “yes” unless information is confirmed by visit, telephone call, confirmation from a local or state agency, or other means to assure that it meets the requirements for inclusion in the OEI. An exception to this statement is certified mammography facilities which are identified by CDRH. Documentation of this decision must be on file either in the factory jacket or other convenient location in district files. Documentation should include at a minimum: date of decision to include the establishment, method and source of information leading to the inclusion, a list of the establishment types and associated industry codes for the establishment, and the name of the employee making the decision. The Form FDA 457, Product/Establishment Surveillance Report, or other district form may be used to document the decision to include an establishment in the active OEI. Establishments placed in the OEI as workload obligation = “yes” should have an initial inspection within two years.




6. Changing establishments from workload obligation = “yes” to “no”

   When the status of an establishment becomes OOB, NOE, or no longer routine inspectional obligation, the workload obligation must be changed from “yes” to “no”. Documentation should also be kept in the establishment file jacket which provides an explanation for the change in an establishment’s workload obligation status to “no”. Registrations and profiles should be updated, as appropriate, before changing the workload obligation.

   1. Establishments should be changed to workload obligation = “no” when:

      1. They go out of business (OOB) entirely

         Note: In FACTS there are no longer individual district files but one national file. If a firm ceases operations in one district and moves to another district, the loosing district should not put the firm out of business. The loosing district would need to change the state, zip code, county and JDTA to the new location in order to transfer ownership of record to the receiving district where the firm is relocating. This would trigger notification to the receiving district’s OEI coordinator. The firm’s factory jackets should be forwarded to the receiving district as well.

      2. They no longer engage in activities or manipulate products subject to FDA regulations - "NOE".

      3. They are no longer subject to inspection or other FDA activities on a recurring cycle because they are either only marginally regulated under the acts and regulations the agency administers or have been identified by the agency as establishments not covered within currently available resources. Individual establishments in this category may periodically be of interest, but are not considered as workload obligation for ORA workplanning. The operational status would be “OPR”.

      4. They are reclassified from manufacturer, repacker, or labeler/relabeler to dealer/retailer because their primary business is retail on premises and they do less than $1,000,000 in wholesale, mail order, and/or internet sales annually. This applies to certain food industry codes identified in the remarks section of Appendix III. The operational status would be “OPR”.




7. Registration Issues (ORA and Centers)

   Although the firm/registration data is integrated into FACTS, the Centers continue to maintain their own registration systems. ORA district offices are responsible for entering registration, listing, and firm data into FACTS. After the Centers receive registration and listing data and enter it into their databases, they forward either a hard copy or send an electronic copy of the registration/listing record to the home district. The district Registration monitor will either enter the new firm/registration into FACTS or update the FACTS firm record if the registration is a renewal. New firm data will not be entered into FACTS without performing a firm search to verify that the firm is not already in the system. FMD 92 Registration and Control Procedures should be reviewed for further guidance.

Appendix I

Content Structure of the OEI and Data Entry Screens

Data regarding firms is entered into FACTS via data entry screens. Screens are available for firm search; firm build, firm merge, firm maintenance, registration, profiles, firm history and for products covered during inspections. Most of these screens can be accessed through the menu bar by choosing options, navigate, or related information. Although most firm data is entered on the Maintain Firms screen, icons are available to access additional screens to include point of contact, postal address, establishment type/industry codes, and cross referencing information. On many screens there are drop down arrows, known as List of Values (LOV), indicating choices for a particular entry. Registration information and profile information are accessed by choosing Options on the menu bar.

Please consult with training manuals and on-line Help screens regarding navigational issues for entering firm data. See FACTS training manuals for examples of all screens.

Prior to entering new firm data, it is critical to access the following search screens in order to determine whether a firm is already in the system: "Name Containing", search by "Name Part I and Name Part II", and "Name Cross Reference-CFN". If duplicates exist in the system, a firm merge screen must be engaged by a user with OEI Coordinator role. There is no delete mechanism in FACTS as was available under FIS. If a firm is incorrectly merged, the data must be re-entered to re-activate the firm. See Appendix IV, section G, for more specific instructions.

Firm changes discovered during the course of an inspection should be modified in FACTS by the investigator by using the factory firm icon button on the Maintain Inspection Results screen.

1. Firm Data

   Districts are responsible for maintaining their establishment inventory by entering new or revised data in the following fields of the firm maintenance screen:

   • Page 1

     • FEI number – Firm establishment identifier number generated by the system. This number cannot be altered.

     • Firm Legal name – The name in FACTS should be entered exactly as it reads on any legal documents or FDA forms (482, 483, etc.). If the firm’s name is “John Q. Smith, M.D.”, the firm should be entered into FACTS as John Q. Smith, M.D. Enter legal name into FACTS in upper and lower case, NOT in all caps, unless portions of the firm’s legal name are specifically in caps.

     • Relationship – Describes relationship between the child firm and parent firm such as subsidiary, overall corporate headquarter, etc.

     • Alias Name – Other names associated with the firm includes Doing Business As (DBAs), merged firm names, etc.

     • Street address – 2 line format: enter with upper and lower case and NOT in all caps. Use approved postal format and abbreviations. Do not enter a P.O. Box in this block. See the following website for approved abbreviations - http://www.usps.com/ncsc/lookups/usps_abbreviations.htm.

     • City – Enter with upper and lower case and NOT in all caps.

     • State – use LOV button

     • Zip Code – required 5 digit code, but enter +4 code if known

     • Country – use LOV button

     • Province – Name of foreign province in which firm is located.

     • Mail Code – postal mail code for a foreign firm

     • County – use LOV button

     • JDTA Code– Judicial district travel area code to identify the geographic location of a firm. See http://web.ora.fda.gov/factsite/JDTAs/ to locate specific codes.

     • FEMA– Site Indicator of whether a firm is within 50 miles of a site of concern (e.g. Nuclear Power Plant).

       • Yes

       • No

     • Area Code

     • Phone Number

     • Extension

     • Fax Number

     • E-mail Address

     • Workload Obligation – Code indicates whether a firm is an on-going regulatory obligation.

       • Yes (previously Active OEI)

       • No (previously Auxiliary OEI)

       • Potential (Interim firm status when a firm is classified as requiring further review by an OEI coordinator)

       • Potential Bioterrorism (Interim firm status when a firm is classified as requiring further review by an OEI coordinator)

     • Profile Required – Indicator of whether a firm is required to be profiled. See IOM Exhibit 5-13, Establishment Profile Criteria, for specificguidance. The system will not allow profile data to be entered unless the checkbox is marked.

     • Registration Required – Indicator of whether a firm is required to register. See FMD 92, Agency Establishment Registration and Control Procedures, for specific guidance.

     • Personal Safety Alert – This check box is marked when a potential hazard has been identified. This is used to advise the investigator that there is a personal safety issue regarding this firm. See IOM 5.2.1.2, Personal Safety Alert, for specific guidance.

     • Inspection responsibility – Code that indicates the type of organization that is responsible for performing the inspection/operation.

       • AP – Accredited Person MDUFMA

       • CC – City/County

       • CE – FDA Center

       • CF – Center/Field

       • CO – Contracts

       • FI – Field

       • FU – Joint FDA/USDA

       • MO – MOU

       • OM – Other Federal Agency/MOU

       • OT – Other Federal Agency

       • PA – Partnership

       • SC – State/Contract

       • SG – State Grant (Cooperative Agreement)

       • SJ – State Contract and Joint FDA/USDA

       • SM – State/MOU

       • SP – State Partnership

       • ST – State

       • TP – Third Party

     • Legal Status – Code that indicates the legal status of the firm.

       • COR – Corporation

       • GOV – Government Entity

       • LIM – Limited Partnership

       • LLC – Limited Liability Corporation

       • OWN – Owner

       • PAR – Partnership

     • Operational Status – Code that indicates the operational status.

       • INA – Inactive (Firm is temporarily non-operational and will resume activities in the future)

       • NOE – Not OEI (Not Official Establishment inventory)

       • OAS – OASIS/NEC (OASIS firm/not elsewhere classified)

       • OOB – Out of Business (Firm out of business for reasons other than having moved)

       • OPR – Operational (Firm is in operation)

       • PRP – Pre-Production (Applies to Device Firms only)

       • SEA – Seasonal (Firm operates during several weeks or months in a year, e.g. cannery which only operates during the harvest season)

     • Operational Status Date – bsystem generated, no user input required

     • Merge Status – system generated, no user input required

     • Reinspection Priority – Code that indicates the priority for the next inspection.

       • 1 – Compliance

       • 2 – Surveillance

       • 3 – Consumer Compliant

     • Rescheduled Inspection Date – For a new firm with workload obligation = “yes”, the recommended reschedule date is 2 years or less. Once a firm has been inspected, the reschedule date is entered by the investigator on the Maintain Inspection Results screen using applicable CPGM guidance.

     • Last Inspection Date – system generated, no user input required

     • Last Violative Inspection Date – system generated, no user input required

     • Last AP Inspection Date – system generated, no user input required

     • Last Attempted Inspection Date – system generated, no user input required. A date is entered into this field by the system when the washout inspection indicator checkbox is marked in the Maintain Investigations screen as a result of a washout inspection. NOTE: Establishment Inspection attempts, OOB Establishment Inspection reports, and NOE results must be entered into FACTS through the maintain investigation screen and not the maintain inspection screen.

     • Last Qualifying Dates – system generated, no user input required

   • Page 2

     • Establishment Size – Code indicating estimated gross annual sales of firm’s products (in dollars).

       • 0 - (0-24,999)

       • 1 - (25,000-49,999)

       • 2 - (50,000-99,999)

       • 3 - (100,000-499,999)

       • 4 - (500,000-999,999)

       • 5 - (1,000,000-4,999,999)

       • 6 - (5,000,000-9,999,999)

       • 7 - (10,000,000-24,999,999)

       • 8 - (25,000,000-49,999,999)

       • 9 - (50,000,000- and over)

       • U - (Unknown)

     • Percent wholesale – Total percentage of firm products that are sold wholesale – food firms only (includes intrastate and interstate).

     • Conveyance Type – Code that indicates the conveyance types for Interstate Travel Program (ITP).

       • A - Airline

       • B - Bus

       • R - Railroad

       • V - Vessel

     • QA Date – Date of last Quality Assurance Review of the information contained in the firm’s electronic record.

     • Electronic Signature Certification [Y/N] – Y indicates that the firm is certified to accept electronic signatures. N indicates that the firm is not certified to accept electronic signatures.

     • Number of employees – Number of employees working at the firm.

     • Percent Interstate – Percent interstate business for the firm’s raw materials and finished products.

     • Brokers Box – Identifies the location where brokers come in and pick up their paper notices.

     • AP Inspection Responsibility End Date – This is the date when the AP Inspection Responsibility ends for the firm and inspectional responsibility reverts back to FDA. Note: The OEI Coordinator must change the Inspection Responsibility Code back to FI, or other appropriate code, from AP.

     • District Use Codes – Codes reserved for Districts.

     • Program/Risk Identifier – Code that identifies and tracks firms under the special Compliance Programs for which a firm is to be inspected. In addition, this field can be used to identify firms with a high level of risk.

   • Screens accessed by Icons

     • Establishment Industry Codes – Click on the factory icon on the Maintain Firms screen to enter these codes. The establishment types and industry code definitions are attached as Appendix V and Appendix VI, respectively, and can also be viewed on the screen through LOV menus.

     • Postal Address – Click on the Letter icon from the Maintain Firms screen to enter the mailing address, city, state, zip code and country. If a firm is a foreign establishment, enter the province and mail code.

     • Point of Contact– Click on the telephone icon from the Maintain Firms screen to enter the Last name, First name, Title, Phone Number, Extension, E-mail and Fax Number of appropriate firm contacts.




2. Profile information

   Profile data must only be entered as a result of a qualifying inspection through the profile icon on the Maintain Inspection Results screen. When appropriate, enter profile class codes, profile validation codes, profile operational types, and profile status codes. List of values are available through LOV buttons associated with these fields. Questions concerning profile data should be directed to your district profile coordinator, DCIQA, or the DCIQA web page http://web.ora.fda.gov/mpqa.

   The following device, biologic, human and veterinary drug establishments are profiled - manufacturer, remanufacturer, reprocessor, packer/repacker, labeler/relabeler, contract sterilizers, control testing laboratories, assemblers of medical device kits, tissue establishments, and specification developers. See IOM Exhibit 5-13 for additional information and instructions.

3. Registration Data

   Registration information can be entered by selecting “Options” from the Maintain Firms screen menu bar to activate the registration screen. Only those users with the district registration monitor role can enter, modify or delete registration data. The following registration data should be maintained:

   • Registration Type Code – Enter the Center to whom firm is registered.

     • BHT – Biologics Human Tissue

     • BIO – Biologics

     • COS – Cosmetic

     • DEV – Device

     • DRG – Drug

     • Food – Note: this registration is automatically entered by the system as a result of a FFRM registration due to the Bioterrorism Act of 2002. This code cannot be entered by any user, including the Registration Monitor.

     • LAC – Low Acid Canned Food

     • RAD – Radiological Health

     • VET – Veterinary Medicine

   • Registration Date – This field reflects the month and year of the registration

   • Submission Type

     • I – Initial

     • R – Re-registration

   • Registration Number – Number assigned by the centers for each Registration Type for a Firm. The Food Registration Number is a unique number generated by the FFRM system. This number is transferred to FACTS via FMLS.

   • Status

     • (A) Current – Firm is currently registered with one or more FDA centers.

     • (C) Canceled - Applicable to all Centers. A code for establishments that are not required to register because their registration was canceled by a center or the establishment was determined OOB or NOE.

     • (E) Exempt - Establishments that process products requiring registration that the center has exempted from registration (excludes biologic and human tissue establishments).

     • (F) Flagged for Cancellation – This code is only available for Food registration.

     • (H) Center for Medicare & Medicaid Services (CMS) (previously Health Care Financing Administration (HCFA)) - FDA is responsible for CMS establishments that manufacture blood and blood components (including blood components for autologous use); and transfusion services where there are indications of non-compliance with GMPs. (See MOU 7155e.03)

     • (M) Military - Military Blood Banks

     • (P) Pre-Production - Establishment that has registered with the Center for Medical Devices and Radiological Health (CDRH) before its production begins.

     • (V) Voluntary - To be used when registration is not required by law or regulation. For example: The Cosmetics Registration File is entirely composed of voluntary registrants or drug warehouses that register voluntarily and therefore do not require biennial inspection.

   • Status Date – Read only field that indicates the status date of the Registration Type.

   • Reason to Cancel – When the user sets the Registration Status to “Flagged for Cancellation” for a Food Registration, the Reason to Cancel must be entered.

   • Additional Registration Info – Additional information regarding the firm registration. LOVs are provided and enabled when data in this field is being entered or changed. Only the applicable codes will appear for each registration type.

     • 0 – Unclassified

     • 1 – Class 1 Devices

     • 2 – Class 2 Devices

     • 3 – Class 3 Devices

     • A – Produces intrastate products only

     • B – Produces ACIDIFIED products only (interstate)

     • C – Produces LACF products only (interstate)

     • D – Produces ACIDIFIED products and LACF products

     • E – Produces LACF pet products only (interstate)

     • F – Produces LACF pet and human products

     • K – Human drugs biologics

     • L – Medicated feed only

     • M – Military Blood Bank

     • O – Veterinary drugs and medicated feeds

     • P – Both human and veterinary dosage form products

     • Q – Human drugs only

     • R – Veterinary dosage drugs only

   • License – Code that indicates the status for a biologic registration. LOVs are provided and enabled when data in this field is being entered or changed.

     • L – Licensed

     • P – Pending

     • U – Unlicensed

   • Critical Device

     • Yes

     • No

   • Sterile Device

     • Yes

     • No

4. Products Covered Data

   Products covered information about a firm can be viewed by choosing “Related Information” on the menu bar while in the Maintain Firms screen. Five-digit process coding and seven-digit product coding are entered through the Maintain Inspection Results screen in FACTS. Full product coding is mandatory if the establishment type is one of the following: manufacturer, repacker, assembler, component manufacturer, contract sterilizers, control lab or growers of industry code 16 (fishery/seafood products) or 69 (medicated animal feeds).

Appendix II

Guidance for Coding Establishments on Firm’s File as Workload Obligation Equal to Yes
or Workload Obligations Equal to No by Establishment Type

Appendix III

Guidance for Coding Establishments on Firm’s File as Workload Obligation to Yes
or Workload Obligations Equal to No by Industry Code
</

Industry Code	Product Description	Workload Obligation = Yes Estab-Types	Workload Obligation = No Estab-Types	Remarks
02 **	Whole grains, soybeans, mill grain products, starches	A,C,EF,M,R, WA,WF,WR, WZ,X,Y,0	A,D,G,L,Q,S	For Industry Code 02 Warehouses, if estab. also warehouses legumes (Industry Code 24), code each 02 & 24 product separately, rather than using the "47" multiple food warehouse code.
03	Bakery products, mixes, icings and dough	A,C,EF,M,R, WA,WF,WR, WZ,X,Y,0	A,D,L,Q,S	Establishments whose primary business is retail on premises are "D" unless doing >$1,000,000 in wholesale, mail order, and/or internet sales annually. Then code as "M".
04	Macaroni & noodle products	A,C,EF,M,R, WA,WF,WR, WZ,X,Y,0	A,D,L,Q,S
05	Cereal Preparations & breakfast foods	A,C,EF,M,R, WA,WF,WR, WZ,X,Y,0	A,D,L,Q,S
07	Snack food items	A,C,EF,M,R, WA,WF,WR, WZ,X,Y,0	A,D,L,Q,S	Establishments whose primary business is retail on premises are "D" unless doing >$1,000,000 in wholesale, mail order, and/or internet sales annually. Then code as "M".
09 **	Milk, butter & dried milk products	A,C,EF,M,R, WA,WF,WR, WZ,X,Y,0	A,D,L,Q,S, WA,WF,WR,WZ	Milk depots & cream stations should be coded "WR" and are Workload Obligation = “no” All other 09 warehouses are Workload Obligations = “yes”. Milk, cheese and ice cream products at the same warehouses should be coded separately 09,12, 13
09CYA	Fresh, raw or natural milk and cream	C,X,0	D,G,Q,S, WR	This code is an IMS program code only
12	Cheese & cheese products	A,C,EF,M,R, WA,WF,WR, WZ,X,Y,0	A,D,L,Q,S	Cheese, milk and ice cream products at the same warehouse should be coded separately - 09, 12, 13
13	Ice cream & related products	A,C,EF,M,R, WA,WF,WR, WZ,X,Y,0	A,D,L,Q,S	Establishments whose primary business is retail on premises are "D" unless doing >$1,000,000 in wholesale, mail order, and/or internet sales annually. Then code as "M". Cheese, milk and ice cream products at the same warehouse should be coded separately - 09, 12, 13
14	Filled milk and imitation milk products	A,C,EF,M,R, WA,WF,WR, WZ,X,Y,0	A,D,L,Q,S
15 **	Eggs and egg products	A,C,EF,G,M,R, WA,WF,WR, WZ,X,Y,0	A,D,G,L,M, Q, S	All egg graders and egg breakers are not a Workload Obligation. Egg farms interstate remain as Workload Obligation.
16	Fishery/Seafood products, filleted, skinned, fresh fish, fresh, raw, natural shellfish (oysters, clams & mussels only). Products containing seafood (i.e., shrimp, egg rolls, crabmeat ravioli) previously Industry Code 37 are now Industry Code 16.	A,C,EF,G,M,R, WA,WF,WR, WZ,X,Y,0,@	A,D,G,L,Q,S,* Seafood harvesting vessels (*) are not a Workload Obligations. However, if the vessel is also processing the seafood, then identify as a Workload Obligation with an establishment type of M and *. Icing and deheading are not processing.	Shellfish coded "@": are Workload Obligations. "S" with Industry Code 16 is not a Workload Obligation. Fish/oyster/crab houses - Establishments whose primary business is retail on premises are "D" unless doing >$1,000,000 in wholesale, mail order, and/or internet sales annually. Then code as "M". Aquaculture establishments marketing seafood directly for human consumption are establishment type "G" and are Workload Obligations.
16J**A	Fresh, raw, natural crustacean (crab, lobster, shrimp, etc.) frozen or refrigerated, other aquatic animal refrigerated or frozen	A,C,EF,G, M, R,WF, WR,X,Y,0	D,L,Q,S	Fish/oyster/crab houses - Establishments whose primary business is retail on premises are "D" unless doing >$1,000,000 in wholesale, mail order, and/or internet sales annually. Then code as "M". 1. M16/WR16 or M16/WF16 a manufacturer warehousing seafood that was not manufactured by the establishment. 2. WR16 or WF16 seafood warehouse only. 3. WR16/WR47 or WF16/WF47 warehouses of seafood and two or more other products not seafood.
17	Meats, meat products and poultry. FDA obligation Fresh, raw, or natural red meat products includes game animals (i.e. venison)	A,C,EF,G,M, R, WA,WF,WR, WZ,X,Y,0	A,D,G,L,M,Q, S,X,	Mandatory USDA obligations and Renderers (Industry Code 17) are not Workload Obligations.
18	Vegetable protein products (simulated meat)	A,C,EF,G,M, R, WA,WF,WR, WZ,X,Y,0	A,D,L,Q,S