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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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(OEI) Development and Maintenance Procedures

Subject:
OEI Development and Maitenance Procedures
Area:
Program Management
Date Revised:
July, 17 2006

 

 

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.  
    3.  

      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.  
        7. 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.  
  3.  

    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.  
    3.  
      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.

    4.  
      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.

    5.  
      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.  
  4.  

    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.

  5.  

    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.

  6.  

    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.

  7.  

    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.  
  7. 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”.
  8.  
  9. 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.  
  3. 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.

  4. 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

  5. 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

 

Establishment Type and Code Workload Obligation = “yes” Workload Obligation = “no” Remarks
Accredited Person (AP)
Industry Codes 73-91 only No Activity for two years  
Accredited Person Firm MDUFMA (AZ)
Industry Code 99 only No Activity for two years  
Acidified Food Processor (MA)
Industry Codes 03, 04, 09, 12, 13, 14, 15, 16, 17, 18, 20, 21, 22, 23, 24, 25, 27, 29, 30, 31, 33, 34, 35, 36, 37, 38, 39, 40, and 41 only.    
American Red Cross Establishment (RC)
Industry Code 57 only    
Assembler (I)
Industry Codes 90 and 94 only (X-ray emitting products).    
Biopharmaceutics Analytical Facility (#)
Industry Code 60-66 only Industry Code 60-66 only Change Workload Obligation to no after 5 years of no FDA activity (e.g., inspection, legal action).
Biopharmaceutics Clinical Facility (2)
Industry Code 60-66 only Industry Code 60-66 only Change Workload Obligation to no after 5 years of no FDA activity (e.g., inspection, legal action).
Blood Banks (B)
Industry Code 57 only Selected CMS (formerly HCFA) Establishments (See remarks) CMS (formerly HCFA) Establishments FDA has responsibility for CMS (formerly HCFA) establishments that manufacture blood and blood components (including blood components for autologous use) and transfusion service. A Hospital Blood Bank storing and dispensing human tissues for the hospital is an end user and is Estab-type B and is a Workload Obligation = “yes” unless CMS (formerly HCFA). A Hospital Blood Bank storing and distributing human tissues to other locations is also a Workload Obligation = “yes” and is estab-type HT and B.
Caterers/Catering Point (J)
Industry Code 51 only   Non-ITP Caterers are coded Public Food Service (P) or Manufacturer (M).
Certifier Domestic MDR (CM)
Industry Codes 73-91 only    
Certified Shellfish Establishments (@)
Industry Code 16 - Establishments covered under the NSSP including Depuration Plants.   If the establishment also does traditional processing activities such as breading, glazing etc., the establishment should also be coded as M for manufacturer.
Clinical Investigator/Animal Clinical Investigator (7)
Industry Codes 45, 46, 54, 56, 57, 60-66, 67, 68, 69, 73-97 only Industry Codes 45, 46, 54, 56, 57, 60-66, 67, 68, 69, 73-97 only Workload Obligation = “no” after 3 years of no FDA activity (e.g., inspection, legal action).
Commercial Sponsor Monitor (4)
Industry Codes 45, 46, 54, 56, 57, 60-66, 67, 68, 69, 73-97 only Industry Codes 45, 46, 54, 56, 57, 60-66, 67, 68, 69, 73-97 only Change Workload Obligation to “no” after 4 years of no FDA activity (e.g., inspection, legal action).
Commissary (K)
Industry code 51 only.   Non ITS commissaries are dealer retailers or warehouses.
Component Manufacturer (Z)
See Manufacturer (M) - Device/Rad Health industry codes only, 73-91 and Radiation Emitting 94-97 (Medical Devices) selling components to end users (e.g., hospitals, dialysis centers) are coded as manufacturers and are workload obligation = ‘“yes” Industry codes 73-91 and 94-97 only - Device/Rad Health and Radiation Emitting Medical Devices selling exclusively to device manufacturers.

Industry code - 68 – Veterinary Devices only.

Industry Code 52 - includes producers of bottle caps.
Device/Rad Health establishments selling exclusively to device mfrs., are exempted from registration and should not be a Workload Obligation. Device/Rad Health Estab., that sell components to end users (e.g., hospitals, dialysis centers) must register and are coded as establishment type Manufacturer (M) and should be coded with Workload Obligation = “yes”
Construction (Conveyances, Support Facilities Components) (H)
Industry code 51 only.    
Contract Research Organization (1)
Industry codes 45, 46, 54, 56, 57, 60-66, 67, 68, 69, 73-97 only. Industry codes 45, 46, 54, 56, 57, 60-66, 67, 68, 69, 73-97 only. Change to Workload Obligation to “no” after 4 years of no FDA activity (e.g., inspection, legal action).
Contract Sterilizer (0) (Zero)
All industry codes except 47, 51, 59, 99    
Control Laboratory (C)
All industry codes except 47, 51, 59, 99    
Conveyance Company (F)
Industry code 51 only   Do not use industry code 51 with establishment types "M", "R", "W"
Corporate Headquarters (Q)
See remarks regarding specification developers of medical devices. All industry codes. Code "Q" for location of headquarters office only.
Dealer/Retailer (D)
*Note: Special Situations - No Dealer/Retailer establishments should be workload obligation = “yes” unless establishment is undergoing investigation or inspection or is under consideration for Regulatory Action. All Industry Codes Except 47, 51, 59, 99.
Includes: -All retailers doing no wholesale business regardless of size. - Manufacturing retail food establishments whose primary business is retail on premises & doing less than $1,000,000 in wholesale sales annually (e.g. retail bakeries, including those in retail grocery stores, candy shops, etc.). - Custom Devices (GMP exempt): Optical Stores/ Companies, (Opticians, Optometrists, etc.) Orthopedic shops, Dental labs, Eyeglass labs, Lens grinders, Finishing labs for hard contact lenses, hearing aid labs. - Grocery stores, butcher shops, health food stores, Drug stores, (pharmacies not required to register). - Pesticide services companies including crop dusters). - Tanning salons/health clubs, spas assembling less than 10 beds/booths. - Rad Health repair shops (using non-certified parts). - Restaurants, cafeterias, delicatessens (including those in retail grocery stores), food vending machine locations not permitted under Public Food Service "P". - Slaughter house/ auction house/sales barn, mobile peddler, mail order facility etc. Change to Workload Obligation = to “yes” if under investigation/ regulatory actions, etc
 
Device Refurbisher (MX)
Industry Codes 73-91 only    
Device User Facility (UF)
Industry Codes 73-91 only    
Donor Center (DC)
Industry Code 57 only    
Entry Filer (EF)
All Industry Codes except 47, 51, 59, 99    
Grower (G)
Industry Code 15, 16, 17, and 69 only.
All Aquaculture establishments marketing seafood for human consumption are currently classified as "G". Includes only:
-Farmers and feed lots requiring a Medicated Feed Mill License to mix medicated feed only for their own animals.
-Establishments with violative tissue residues, undergoing investigation or inspection or pending regulatory action. Additionally, an importer/broker who takes physical possession of regulated articles should be coded as a workload obligation = “yes”.
Industry Codes 02, 09, 17, 20-25, 26, 28, 31, 34, 36, 52, 54, 55, 69, 70 only.
Includes:-Farmers and feedlots using a drug exempt from a Medicated Feed Mill License (FD-1900) to mix medicated feed, only for their own animals. Farms, feed lots.
Establishments with tissue residue reported but no follow-up planned. Previously violative establishments with no additional violations within the past 3 years should be workload obligation = “no”
An establishment that grows the seafood, and processes the finished product (gutting, deheading, glazing, filleting, etc.), should be coded G for Grower and M for Manufacturer.
Human Tissue Establishment (HT) NOTE: All tissue firms should be identified as HT and possibly one or more of the three types below (HR, HS, RO).
Industry Code 57, 66, and 99 only   Tissue establishments in the OEI include all establishments engaged in the recovery, screening, testing, processing, storage and/or distribution of human tissue. A Hospital Blood Bank storing and dispensing tissues for the hospital is an end user and is Estab-type B, and a workload obligation equal to “yes” unless CMS (formerly HCFA). A hospital blood bank storing and distributing human tissues to other locations is also a workload obligation = “yes” and is estab-type HT and B.
Human Tissue Reproductive Establishment (HR)
Industry Code 57, 66, 99   Tissue establishments in the OEI include all establishments engaged in the recovery, screening, testing, processing, storage and/or distribution of human reproductive tissue. Workload obligation = "Yes" and is estab-type HT and HR.
Human Tissue Stem Cell Establishment (HS)
Industry Code 57, 66, 99   Tissue establishments in the OEI include all establishments engaged in the recovery, screening, testing, processing, storage and/or distribution of human stem cells. A Hospital Blood Bank storing and dispensing stem cells for the hospital is an end user and is Estab-type B, and a workload obligation equal to "Yes" unless CMS. A Hospital Blood Bank storing and distributing human stem cells to other locations is also a workload obligation = "Yes" and is estab-type HT, HS and B.
Human Tissue Establishment engaged in recovery operations (RO)
Industry Code 57, 66, 99   Tissue establishments in the OEI include all establishments engaged in the recovery of human tissue. Recovery means obtaining from a donor cells or tissues that are intended for use in human transplantation. Recovery is sometimes referred to as procurement or harvest. Establishments may only perform recovery or may engage in other tissue manufacturing operations. Workload obligation = "Yes" and is estab-type HT and RO.
Importer/Broker (A)
All Industry Codes that are either Biologics; Food HACCP; initial distributors of Medical Devices - Industry Codes 73-91, & Radiation Emitting Medical Devices - Industry Codes 94-97, which are required to register. Additionally, an importer/broker who takes physical possession of regulated articles should be coded as workload obligation = “yes”.
Industry Codes 47, 51, 59, and 99 are not valid codes for this establishment type.
All Industry Codes which do not meet the criteria listed under workload obligation = “yes” and for which the imported/broker does not take physical possession of the regulated article. Industry Codes 47, 51, 59, and 99 are not valid codes for this establishment type.  
Institutional Review Committee (IRC) for Human Studies (8)
Industry Codes 54, 56, 57, 60-66, 73-97 only. Industry Codes 54, 56, 57, 60-66, 73-97 only. Change to Workload Obligation = “no”, after 5 years of no FDA activity (e.g., inspection, legal activity).
Labeler/Relabeler (Y)
All Industry Codes except 70. Industry Codes 47, 51, 59, and 99 are not valid for this establishment type.

Includes: -Brokers of blood components (relabeled plasma from blood already salvaged).
Industry Code 70 only Do Not Code: "WA, WF, WR, or WZ" for in-process or storage areas of finished products labeled/relabeled by the establishment. "Q" for corporate headquarters located at the relabeler. "S" for Shipper when part of the labeling/ relabeling operation.
Low Acid Canned Processor (ML)
Industry Codes 03, 04, 09, 12, 13, 14, 15, 16, 17, 18, 20, 21, 22, 23, 24, 25, 27, 29, 30, 31, 33, 34, 35, 36, 37, 38, 39, 40, and 41 only    
Mammography Facilities (E)
Industry Code 90 only (X-ray emitting product)   Mammography facilities only. Does not include manufacturers of Mammography equipment.
Manufacturers (M)
All Industry Codes except 47, 51, 59, and 99, which are not valid codes for this establishment type. Includes: -Laser show producers. -Laser assemblers. -Bottlers. -Intermediate processors, i.e., micro-encapsulation. -Certified Shellfish estab., if they perform processing such as shucking, breading, glazing etc. -Aquaculture establishments if they process the finished product such as filleting, glazing, deheading, etc. -Milk plants (dairies) -Pet Food Mfrs.
-Renderers (Ind Code 71). Any estab., using a drug requiring a Medicated Feed Mill License to mix medicated feed for sale and required to register.Non-medicated Animal Feed Mills, Industry Code 70 handling prohibited material subject to coverage under the BSE program. -Tanning salons/health clubs, spas assembling 10 or more beds/booths (non-exempt). -Specification developers of medical devices. -Establishments producing kitchen tableware, food related items. -Certain food establishments doing $1,000,000 or more in annual wholesale volume. All food establishments whose primary business is wholesale, regardless of volume. See Dealer/Retailer for other types of quasi manufacturers that should not be classified as "M" - Manufacturers of mammography equipment.
All Industry Codes except 47, 51, 59, and 99, which are not valid codes for this establishment type. Includes: - Animal Device manufacturers. -Chemical companies (excluding drug and excipient mfrs. -Egg graders & breakers -Nuclear Pharmacies -Renderers (Industry Code 17). -Sole USDA obligations (meat, poultry plants, and slaughter houses. Non-medicated Animal Feed Mills, Industry Code 70
-Any establishment using a drug exempt from a medicated feed mill license to mix medicated feed for sale and not required to register unless subject to coverage under BSE program.
-Caterers dealing with the general public which are not covered by establishment types Caterer, or Catering Point (J) or Public Food Service (P).-Seafood Harvesting Vessels that do not process the product.
-Tanning salons/health clubs, spas assembling less than 10 beds/ booths (exempt).
-Small specialty bakeries, candy shops, fish, crab or oyster houses, snack food items (i.e. caramel corn, popped popcorn, pretzels, etc.), wineries, cider mills, apiaries (unless they produce the honey), etc. If an establishment’s primary business is retail on premises and it does less than $1,000,000 in annual wholesale sales, it should be classified as a "D" for Dealer/Retailer. Also see Dealer/ Retailer for other types of quasi manufacturers that should not be classified as "M".
Do Not Code: "W" for raw material, in process or storage areas of finished products manufactured by the establishment. "Q" for corporate headquarters located at the mfr., unless it identifies products not manipulated at the location. "S" for shippers when part of the manufacturing operation.
Medical Gas Manufacturer (MG)
Industry Code 60-66 and 73-91 only   Includes: Air liquefaction plants, all transfilling operations of medical gas (gaseous and liquid), on site or vehicle mounted.
Methadone Clinics (and other drug abuse treatment centers) (T)
  Industry Code 60 only  
Monitor (Non-Sponsor) (6)
Industry Codes 45, 46, 54, 56, 57, 60-66, 67, 68, 69, 73-97 only. Industry Codes 45, 46, 54, 56, 57, 60-66, 67, 68, 69, 73-97 only Change to Workload Obligation = to “no” after 4 years of no FDA activity (e.g., inspection, legal action).
Non-Clinical Laboratories (9)
Industry Codes 45, 46, 54, 56, 57, 60-66, 67, 68, 69, 73-97 only. Industry Codes 45, 46, 54, 56, 57, 60-66, 67, 68, 69, 73-97 only. Change to Workload Obligation = “no”, after 4 years of no FDA activity (e.g., inspection, legal activity).
Own Label Distributor (L)
Industry Codes 54, 56, 60-66.

Other codes allowed if the establishment is under consideration for legal action, inspection or investigation.

Industry Codes 47, 51, 59, and 99 are not valid codes
All Industry Codes except 54, 56, 60-66.

Industry Codes 47, 51, 59, and 99 are not valid codes.
 
Plasmapheresis Center (3)
Industry Code 57 only.    
Public Food Service (P)
Industry Code 51 only.

Includes: Federal Food Contractors, vendors, and federal agencies (e.g. GSA establishment cafeterias, wet stands, etc.).
Industry Code 51 only.

Includes: Only food establishments requested by Secret Service for protection of prominent individuals or groups, or inspected as a result of foodborne illness.
Do Not Include: Establishments covered during certification/ standardization of state employees or any other retail food protection state program. Caterers dealing with the general public which are not covered by this establishment type or Caterers/Catering Point (J) are coded Manufacturer (M).
Remanufacturers (MR)
Industry Code 73-91 only
 
Repacker/Packer (R)
All Industry Codes.

Includes:
-Brokers of blood components (repack plasma from blood already salvaged)-
Produce packing sheds engaged in repacking, washing waxing.

Industry Codes 47, 51, 59, and 99 are not valid with this establishment type.
Industry Codes 47, 51, 59, and 99 are not valid with this establishment type.

Produce packaging sheds, repacking only (into smaller containers)

Industry Codes 20-22, 24-25

Non-Medicated Animal Feed. Industry Code 70
Code: "WA, WF, WR, or WZ" for packing sheds that are holding stations operated by an individuals or cooperative grower.
"S" for shipper when part of the repacking operation.
Reprocessor (MB)
Industry Codes 73-91 only    
Salvage Operation (X)
All Industry Codes except 17, 32, and 70 unless they handle or may handle prohibited materials (BSE) (used mainly for foods). Industry Code 51 not valid for this establishment type

Includes: -Repackers -Wholesalers -Shellfish Depuration Plants
Industry Codes 17, 32, and 70 onlyunless they handle or may handle prohibited materials (BSE). Then they are workload ‘Yes’. When inspecting single industry products (e.g., mushrooms) at multiple industry salvage operations, use the multiple industry code only.
Seafood Harvesting Vessel * (asterisk)
Industry Code 16 only. If the vessel processes the product in any manner also code "M" for manufacturing (include gutting, scaling, filleting, glazing, etc.). Icing and deheading are not considered processing. If the vessel does no processing. Icing and deheading are not considered processing This classification includes all commercial vessels that harvest seafood products and do not sell products directly to the public. Use this code in conjunction with other Establishment Type Codes if applicable.
Service Area (V)
Industry Code 51 only.    
Shippers (S)
Industry Code 16 (certified Shellfish only) All Industry Codes except 16 (certified Shellfish)

Industry Codes 47, 51, 59, and 99 are not valid with this establishment type.
Use code "S" in conjunction with other Establishment Type Codes or only for establishments having no other responsibility for a product such as manufacturing, storage, or repacking.
Software Manufacturer (MW)
Industry Code 57, 73-91 only    
Sponsors-Investigators (5)
Industry Code 45, 54, 56, 57, 60-66, 67, 68, 73-97 only. Industry Code 45, 54, 56, 57, 60-66, 67, 68, 73-97 only. See Remarks Change to Workload Obligation = “no”, after 4 years of no FDA activity (e.g., inspection, legal activity).
Warehouse (W) No longer an active establishment type. See specific warehouse establishment types below for guidance.
     
Warehouse-Ambient Storage (WA)
Includes: -All Industry Codes except 29, 32, 53, 70, 71, 72, and 73-97.
Industry Code 51 not valid with this establishment type.

Include:
-Grain elevators used for human food.
-Brokers of blood components (stored plasma from blood already salvaged).
-Wholesale produce.
-Multiple food use Industry Code 47.
-Multiple human drugs use Industry Code 59.
-biologics, veterinary products or any combination thereof, use Industry Code 99.
Industry Codes 29, 32, 53, 70, 71, 72 and 73-97.

Includes:
-Bakery transfer depots.
-Beer, liquors, wines, beverages, soft drink warehouses.
-Cosmetics (beauty supplies, etc.).
-Vending machines and snack food depots.
-Elevators used only for animal food (non-medicated).
-Milk depot, cream station.
- Products stored under USDA jurisdiction (e.g., meat).
-Transfer stations, receiving stations, etc., added to the OEI under the IMS Program.
-Produce Packing Sheds.
-Non-medicated animal feed. -Multiple medical devices, radiation emitting devices,
Coding Food Warehouses
1. Multiple Food: Generally house all kinds of food. To qualify as a multiple food warehouse the establishment must store 3 or more different industry codes. They may be inspected for various reasons, including sanitation, or to search for recalled goods (such as canned mushrooms, tuna fish, etc.). When inspecting single industry products at a multiple food warehouse, use industry code 47 only.
2. Specialty warehouses: One product, or limited groups of similar products warehouses should be coded with one or more codes that clearly indicate the specialty (i.e., 29 & 41 - soda ; 02 & 24 – grains & legumes; 33 & 34 - candy; 09 & 12 – dairy; and 20-22 & 24-25 produce warehouse/ packing shed).
M16/WA16 or WA16 manufacturer warehousing seafood not manufactured.
WA16 seafood warehouse only.
WA16 or WA16/W47 warehouse of fresh/frozen seafood and two or more products.
Warehouse-Ambient, Refrigerated, and Frozen Storage (WZ)
All Industry Codes except 29, 32, 53, 70, 71, 72, and 73-97. Industry Code 51 not valid with this establishment type.

Include:
-Frozen food warehouses
-Grain elevators used for human food.
-Brokers of blood components (stored plasma from blood already salvaged).
-Wholesale produce.
-Multiple food use Industry Code 47.
-Multiple human drugs use Industry Code 59.
-biologics, veterinary products or any combination thereof, use Industry Code 99.
Industry Codes 29, 32, 53, 70, 71, 72 and 73-97

Includes:
-Bakery transfer depots.
-Beer, liquors, wines, beverages, soft drink warehouses.
-Cosmetics (beauty supplies, etc.).
-Vending machines and snack food depots.
-Elevators used only for animal food.
-Milk depot, cream station.
- Products stored under USDA jurisdiction (e.g., meat).
-Transfer stations, receiving stations, etc., added to the OEI under the IMS Program.
-Produce Packing Sheds.
-Non-medicated animal feed. -Multiple medical devices, radiation emitting devices,
Coding Food Warehouses
1. Multiple Food: Generally house all kinds of food. To qualify as a multiple food warehouse the establishment must store 3 or more different industry codes. They may be inspected for various reasons, including sanitation, or to search for recalled goods (such as canned mushrooms, tuna fish, etc.). When inspecting single industry products at a multiple food warehouse, use industry code 47 only.
2. Specialty warehouses: One product, or limited groups of similar products warehouses should be coded with one or more codes that clearly indicate the specialty (i.e., 29 & 41 soda,; 02 & 24 – grains & legumes; 33 & 34 - candy; 09 & 12 – dairy; and 20-22 & 24-25 produce warehouse/ packing shed).
M16/WZ16 manufacturer warehousing seafood not manufactured.
WZ16 seafood warehouse only.
WZ16/WZ47 warehouse of fresh/frozen seafood and two or more products.
Warehouse-Frozen Storage (WF)
Industry Codes 03, 04, 09, 13, 15, 16, 18, 20,21, 22, 24, 25, 30, 34, 35, 37, 38, 39, 40, 47, 54, 57, 59, 66, and 99

Include:
-Frozen food warehouses
-Brokers of blood components (stored plasma from blood already salvaged).
-Wholesale produce.
-Multiple food use Industry Code 47.
-Multiple human drugs use Industry Code 59.
-biologics, veterinary products or any combination thereof, use Industry Code 99.
Industry Codes 17, 53, 68, 81, 82, 83, 88, 91

Includes: - Products stored under USDA jurisdiction (e.g., meat).
-Cosmetics (beauty supplies, etc.).
-Animal Devices and Diagnostic Products
-Multiple medical devices, radiation emitting devices,
Coding Food Warehouses
1. Multiple Food: Generally house all kinds of food. To qualify as a multiple food warehouse the establishment must store 3 or more different industry codes. They may be inspected for various reasons, including sanitation, or to search for recalled goods (such as canned mushrooms, tuna fish, etc.). When inspecting single industry products at a multiple food warehouse, use industry code 47 only.
2. Specialty warehouses: One product, or limited groups of similar products warehouses should be coded with one or more codes that clearly indicate the specialty (i.e., 29 & 41 soda; 02 & 24 – grains & legumes; 33 & 34 - candy; 09 & 12 – dairy; and 20-22 & 24-25 produce warehouse/ packing shed).
M16/WF16 or WF16 manufacturer warehousing seafood not manufactured.
WF16 seafood warehouse only.
WF16 or WF16/WF47 warehouse of fresh/frozen seafood and two or more products.
Warehouse-Refrigerated Storage (WR)
All industry codes except 29, 32, 53, 70, 71, 72, 75, 81, 82, 83, 88, and 91

Industry Codes 05, 07, 28, 33, 50, 51, 52, 55, 67, 73, 74, 76, 77, 78, 79, 80, 84, 85, 86, 87, 89, 90, 94, 95, 96, and 97 are not valid for this establish type.

Include:
-Brokers of blood components (stored plasma from blood already salvaged).
-Wholesale produce.
-Multiple food use Industry Code 47.
-Multiple human drugs use Industry Code 59.
-biologics, veterinary products or any combination thereof, use Industry Code 99.
Industry Codes 29, 32, 53, 70, 71, 72, 75, 81, 82, 83, 88, and 91

Includes:
-Bakery transfer depots.
-Beer, liquors, wines, beverages, soft drink warehouses.
-Cosmetics (beauty supplies, etc.).
-Vending machines and snack food depots.
-Elevators used only for animal food.
-Milk depot, cream station.
- Products stored under USDA jurisdiction (e.g., meat).
-Transfer stations, receiving stations, etc., added to the OEI under the IMS Program.
-Produce Packing Sheds.
-Non-medicated animal feed.
-Multiple medical devices, radiation emitting devices,
Coding Food Warehouses
1. Multiple Food: Generally house all kinds of food. To qualify as a multiple food warehouse the establishment must store 3 or more different industry codes. They may be inspected for various reasons, including sanitation, or to search for recalled goods (such as canned mushrooms, tuna fish, etc.). When inspecting single industry products at a multiple food warehouse, use industry code 47 only.
2. Specialty warehouses: One product, or limited groups of similar products warehouses should be coded with one or more codes that clearly indicate the specialty (i.e., 29 & 41- soda; 02 & 24 – grains & legumes; 33 & 34 - candy; 09 & 12 – dairy; and 20-22 & 24-25 produce warehouse/ packing shed).
M16/WR16 or WR16 manufacturer warehousing seafood not manufactured.
WR16 seafood warehouse only.
WR16 or WR16/WR47 warehouse of fresh refrigerated seafood and two or more products.
Watering Point (U)
Industry Code 51 only.    




 

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  
20-22 **
Fruit and fruit products, fruit packing sheds A,C,EF,G,M, R,
WA,WF,WR,
WZ, X,Y,0
A,D,G,L,Q,S Cider mills - 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". "D"- packing sheds are not Workload Obligations unless waxing or washing produce.
23 **
Nuts and edible seeds. Fresh raw or natural nuts in shell, refrigerated or frozen. A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,G,L,Q,S  
24-25
Beans, peas, corn, fruits used as vegetables, leaf and stem vegetables, mushrooms and truffles, mixes vegetables, root and tuber vegetables, produce packing sheds. A,C,EF,G,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,G,L,Q,S, WA,WF,WR, WZ,R For Industry Code 24 Warehouses, if establishment also warehouses grains (Industry Code 02), code each 02, 24 product separately, rather than using industry code 47 - multiple food warehouse. Use the warehouse codes for wholesale produce or independently owned wholesale produce establishment publicly storing for a grower - "G".
Produce packing sheds are Workload Obligation = “no” unless washing and waxing.
Produce packing sheds – of fresh mushrooms in airtight plastic wraps are workload obligations. Growers of mushrooms grown on sterile media, not washed, not heated-treated and in airtight plastic wraps are Workload Obligation = “yes”.
26
Vegetables oils (includes Olive Oils) A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,L,Q,S  
27
Dressings and Condiments A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,L,Q,S  
28 **
Spice, flavors and salt, fresh, raw natural whole spices. Fresh, raw natural material for extracts and flavors. A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,G,L,Q,S  
29
Soft drinks and waters. Includes bottled spring & mineral water and manufactured ice. A,C,EF,
M,R,X,Y,0
A,D,L,Q,S, WA,WF,WR, WZ Warehouses of both regular and diet soft drinks (Industry Code 41) should be coded separately under Industry Codes 29 and 41 instead of under Industry Code 47 Multiple Foods Warehouse.
30
Beverage bases A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,L,Q,S  
31
Coffee and tea A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,L,G,Q,S,  
32
Alcoholic beverages, imitation wines, and liquors A,C,EF,
M,R,X,Y,0
A,D,L,Q,S, WA,WF,WR, WZ,X Wineries 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".
33
Candy without chocolate, candy specialties, and chewing gum 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".
34 **
Cocoa beans,
Chocolate and cocoa products. Includes candy with chocolate.
A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,G,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".
35
Gelatin, rennet,
pudding mixes, and pie fillings
A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,L,Q,S  
36
Sugar Products, food sweeteners, nutritive syrups, honey and molasses, imitation syrups, molasses and honey A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,G,L,Q,S Apiaries (honey)/maple syrup producers. 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".
37
Multiple food dinners, gravies, sauces, and specialties (Total Diet), sandwiches, paste (some paste see Industry Codes 16, 21, 24, 25) Products containing seafood (i.e., shrimp, egg rolls, crabmeat ravioli) previously Industry Code 37 are now Industry Code 16 A,,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,L,M,Q,S Catering services dealing with the general public (not covered under ITP or Retail Food programs) should be coded "M 37" and are a Workload Obligation. Note: Open face sandwiches containing meat ="USDA," Bread on both sides (closed sandwich) = FDA. See IOM Exhibit 3-1.
38
Soups A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,L,Q,S  
39
Prepared salad products A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,L,Q,S  
40
Baby (infant and junior) food products A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,L,Q,S  
41
Dietary conventional foods and meal replacement, foods with/without supplemental nutrients, geriatric foods A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,L,Q,S Warehouses of both diet and regular soft drinks (Industry Code 29) should be coded separately (Industry Codes 41 and 29) instead of using the 47 multiple food warehouse code.
45 **
Food additives - human use A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,
0,1,4, 5,6,7,9
A,D,L,Q,S,1,4,5,6,7,9 Workload Obligation = “no” Estab-type 7, after 3 years and Estab-type 1,4,5,6,9, after 4 years with no FDA activity (e.g., inspection, legal action).
46
Food additives - human use A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,L,Q,S  
47
Multiple food warehouse (Use "47" for establishments that store items from at least 3 different industry codes.) WA,WF,WR, WZ, X Q This establishment type requires no additional product coding. Do not use "47" for warehouses of the following product combinations: Regular/Diet soft drinks,
Grains & Legumes, Cheese, Milk & Ice Cream, Produce, Chocolate/Non Chocolate Candy. Use specific industry code whenever possible. (02 or 24 etc.)
50
Color additives for food, drugs, and cosmetics A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,L,Q,S  
51
Food services and conveyances (For non ITP, non Retail Food program establishments, See Industry Code "37") F,H,J,K,
P,U,V
Q,P Product classes R,S,T,V,Y are used for Carrier Sanitation C.P. work only. Non ITP caterers are "M 37s". Federal food contractors, vendors, and agencies (i.e. GSA) are a Workload Obligation. Estabs. requested by Secret Service are not a Workload Obligation.
52
Miscellaneous food related items (exhibits, items for evidence development, etc., also includes kitchenware, tableware, etc., water samples from growing areas. A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,G,L,Q,S,Z Producers of bottle caps are component manufacturers and should be coded as Workload Obligation = “no”
53
Cosmetics A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,L,Q,S, WA,WF,WR, WZ  
54
Vitamins, minerals, proteins, and unconventional dietary supplements for food use. Vitamins and minerals for animals. A,C,EF,L,M,R,
WA,WF,WR,
WZ,X,Y,
0,1,4, 5,6,7,8,9
A,D,G,Q,S,1,4,5,6,7,8,9 Change status to Workload Obligation = “no” for Estab-type 7, after 3 years; Estab-type 1,4, 5,6,9, after 4 years; Estab-type 8 after 5 years of no FDA activity (e.g., inspection, legal action).
55
Pharmaceutical necessities and containers for drugs and biologics. A,C,EF,MG,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,G,L,Q,S  
56 **
Antibiotics for human and animal use A,C,EF,L,M,R,
WA,WF,WR,
WZ,X,Y
,0,1,4,56,7,8,9
A,D,Q,S,1,4,5,67,8,9 Change status to Workload Obligation = “no” for Estab-type 7, after 3 years; Estab-type 1,4, 5,6,9, after 4 years; Estab-type 8 after 5 years of no FDA activity (e.g., inspection, legal action).
57
Biologics and licensed in-vitro diagnostic products A,B,C,DC,EF,
HT,M,MW,R,
RC,WA,WF,
WR,WZ,X,Y,
0,1,3,4,5,6,7,8,9
1,4,5,6,7,8,9 Industry Code "R" includes brokers of blood components (repackers of plasma from salvaged blood). Code "Y" includes brokers of Blood components (RC Plasma from blood already salvaged). Most CMS (FORMERLY HCFA) estab., are not a Workload Obligation. Except establishments that manufacture blood components (including blood components for autologous use.). Change status to Workload Obligation = “no” for Estab-type 7, after 3 years; Estab-type 1,4,5, 6,9, after 4 years; Estab-type 8 after 5 years if no FDA activity. (e.g. inspectional, legal action).
59
Multiple drug warehouse WA,WF,WR, WZ,X Q This establishment type requires no other product coding. Does not include Biologics/in-vitro. See Industry Code "99".
60-66 **
Human drugs (Rx and Non-Rx) A,C,DC,EF,
HT,L,M,MG,M,R,RC,
WA,WF,WR,
WZ,Y,0,1,
2,4,5,6,7,8,9,#
A,1,2,4,5,6,7,8,9,# Nuclear pharmacies are not a Workload Obligation. Change status to Workload Obligation = “no” for Estab-type 7, after 3 years; Estab-type 1,4,5,6,9, after 4 years; Estab-type 8,2,# after 5 years of no FDA activity (e.g., inspection, legal action).
67
Type A Medicated Articles A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0,1,4,
5,6,7,9
A,1,4,5,6,7,9 Change status to Workload Obligation = “no” for Estab-type 7, after 3 years; Estab-type 1,4,5,6,9, after 4 years of no FDA activity. (e.g., inspection, legal action).
68 **
Animal drugs, devices and diagnostic products for animals. A,C,EF,M,R,
WA,WF,WR,
WZ,X,Y,0,1,4,
5,6,7,9
A,M,R,Y,1,4,5,6,7,9 Workload Obligation = “no” for "Z" applies to Device & Rad Health estabs not selling to end users. These "Z's" are exempt from registration. Animal device manufacturers/ repackers/relabelers are not a Workload Obligation unless they are under regulatory consideration, under investigation or inspection.

Animal Drug repackers are a Workload Obligation. Animal device repackers are not a Workload Obligation . Change status to Workload Obligation = “no” for Estab-type 7, after 3 years; Estab-type 1,4,5,6,9, after 4 years of no FDA activity. (e.g., inspection, legal action).
69
Medicated animal feeds (includes feed supplements and rations) A,C,EF,G,M,R,
WA,WF,WR,
WZ,X,Y,0
A,D,G,L,M,Q,S Code "G" are Workload Obligations = “yes” for establishments using drugs requiring a Medicated Feed Mill License and mixing medicated feed only for their own animals.

Tissue residue firms are coded "G".

"M" & "G" are Workload Obligation = “no” for establishments with cancelled registrations and not requiring a Medicated Feed Mill License. Feed mills handling prohibited materials (BSE) are Workload Obligation = “yes”.
70
Non-medicated animal feed A,C,EF,0 A,D,G,L,M,
Q,R,S,WA,
WF,WR,WZ ,
X,Y
Feed mills handling prohibited materials (BSE) are Workload Obligation = “yes”.
71
By-products for animal foods A,C,EF,M,R,XY,0 A,D,L,Q,S,
WA,WF,WR,
WZ
Renders of animal by-products are "M-71" and are Workload Obligation = “yes” due to problems associated with tissue residues and chemical contaminants.
72
Pet and laboratory animal foods A,C,EF,M,R,XY,0 A,D,L,Q,S, WA,WF,WR, WZ  
73
Anesthesiology (devices) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9 Non-workload Obligation "Z" applies to Device & Rad-Health estabs, not selling to end users. These "Z's" are exempt from registration. "Z's" who are selling to end users are required to register and should be coded as "M".

All registered establishments must be coded as Workload Obligation = "yes". This includes establishment type A (initial distributors); and Estab-types M,R,Y,0 of exempted class I medical devices.

Change status to Workload Obligation = “no” for Estab-type 7 after 3 years; Estab-type 1,4,5,6,9, after 4 years; Estab-type 8 after 5 years of no FDA activity (e.g. , inspectional, legal action).
74
Cardiovascular (devices) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
75
Chemistry (diagnostic) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
76
Dental (devices) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
77
Ear, nose, throat (devices) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
78
Gastroenterological and Urological (devices) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
79
General and plastic surgery (devices) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
80
General Hospital and personal use (devices) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9 Non-workload Obligation "Z" applies to Device & Rad-Health estabs., not selling to end users. These "Z's" are exempt from registration. "Z's" who are selling to end users are required to register and should be coded as "M".

All establishments that are registered must be coded as Workload Obligation = "yes". This includes establishment type A (initial distributors); and Estab-types M,R,Y,0 of exempted class I medical devices.

Change status to Workload Obligation = “no” for Estab-type 7 after 3 years; Estab-type 1,4,5,6,9, after 4 years; Estab-type 8 after 5 years of no FDA activity (e.g., inspectional, legal action).
81
Hematology (diagnostics) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
82
Immunology (diagnostics) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
83
Microbiology (diagnostics) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
84
Neurological (devices) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
85
Obstetrical and gynecological (devices) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
86
Ophthalmic (devices) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
87
Orthopedic (devices) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
88
Pathology (diagnostic) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
89
Physical medicine (devices) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
90
Radiological (devices) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
91
Toxicological (diagnostic) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
94
Ionizing (Rad Health) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
95
Light (Rad Health) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
96
Microwave, including RF (Rad Health) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9
97
Sound (Rad Health) A,C,CM,EF,
M,MR,MX,
M,R,UF,X,Y,Z,0,
1,4,5,6,7,8,9
A,D,L,Q,S,Z, WA,WF,WR, WZ,1,4,5,6,7,8,9 Non-workload Obligation "Z" applies to Device & Rad-Health estabs., not selling to end users. These "Z's" are exempt from registration. "Z's" who are selling to end users are required to register and should be coded as "M".

All establishments that are registered must be coded as Workload Obligation = "yes". This includes establishment type A (initial distributors); and Estab-types M,R,Y,0 of exempted class I medical devices.

Change status to Workload Obligation = “no” for Estab-type 7 after 3 years; Estab-type 1,4,5,6,9, after 4 years; Estab-type 8 after 5 years of no FDA activity (e.g., inspectional, legal action).
99
Multiple product storage warehouse for biologics, medical devices, radiological devices and veterinary medicine. WA,WF,WR, WZ,X Q  




 

Appendix IV

General Rules and Guidance for Assignment of Firm Establishment Identifiers

 

Assignment of Firm Establishment Identifiers (FEIs)

Under FIS the Central File Number (CFN) was the primary identifier of establishments in the OEI. With the implementation of FACTS, the CFN was replaced with a firm establishment identifier (FEI) which is automatically generated by the system. However, the old CFNs remain available within the firm’s module under the cross reference screen. In some cases, the FEI number and CFN are the same; in those cases where they are different, all hard copy files should be identified with the FEI number.

  1. General Information about the Use of Firm Establishment Identifier Numbers.

    In most instances, the assignment of a FEI is straightforward. When an establishment is identified as belonging in the OEI, it is automatically assigned the next sequential number by the system.

    When a firm moves from one district to another, there is no need to set the operational status to Out of Business (OOB) as was previously done in FIS. The firm will keep the same FEI number regardless of a change in home district, legal name, and address. A record will be automatically created in the FACTS firm history table.

    It should be emphasized that the main purpose of the FEI is the identification of establishments and the maintenance of an establishment’s record of operations and products.

  2. Guidelines

    1. Firms should be coded with workload obligation = “yes” when the establishment is an inspectional obligation. If regulatory action is being pursued against a firm or its products which by definition would normally be coded as workload obligation = “no”, then these firms should temporarily be coded workload obligation = “yes” until regulatory activity ceases.
    2. The FEIs must never be changed, even though the establishment may change location, ownership, or establishment name. An FEI should be issued for the legal name of the firm, not DBA (Doing Business As), or aka (also known as). DBAs and akas should be listed under “Alias” on the Maintain Firms screen in FACTS.
    3. A location will have one FEI for any combination of establishment types unless the establishment types are different corporate entities. The exceptions to this rule are:

      1. Each Methadone Clinic must have a separate FEI. (Note: at this time, FDA no longer has inspection responsibilities for these firms; however, they are still identified in the system.)
      2. Each Clinical Investigator must have a separate FEI.
      3. Each IRB must have a separate FEI.
      4. Each mammography facility must have a separate FEI

        Note: CDRH assigns facility ID numbers which are not part of FACTS. These facility ID numbers must have separate FEIs associated with them. Two mobile units affiliated with the same facility and each bearing separate facility ID numbers must have separate FEIs. Two clinics within the same hospital, e.g. Radiology Department and women’s health clinic, bearing separate facility I.D. numbers, must also have separate FEIs.

    4.  
    5. FEI for Blood Banks and Donor Centers

      Blood banks and donor centers, licensed or unlicensed, are assigned FEIs based on the standard rules. They will not have a unique FEI for each function. There are instances where establishments are co-located. For example: a donor center is located at the same hospital as a transfusion service or hospital blood bank. The donor center is under the same ownership and license as a full service community blood bank at another location. The donor center will have the same license as the full service blood bank; however, the FEI will be unique to the location. Therefore, one FEI is assigned to the donor center located in the hospital, a second FEI is assigned to the full service blood bank located outside the hospital, and a third FEI is assigned to the hospital which includes the transfusion service or hospital blood bank. Thus, one FEI for the hospital, one FEI for the licensed donor center, and one FEI for the full service community blood bank holding the license.

    6. FEI for Non-Commercial Organizations

      1. A university will have a separate FEI for each school, college, or hospital that is an inspectional obligation affiliated with or located on the same campus. Separate campuses will have separate FEIs.
      2. Government facilities will be assigned FEIs based on organizational responsibility within the overall agency or organization. e.g., when FDA’s CFSAN laboratory and CDER's laboratory were both co-located at FOB-8, each was assigned its own FEI. Each institute located on the NIH campus in Bethesda, Maryland, such as the National Cancer Institute, will have a separate FEI. Separate locations will have separate FEIs.
    7.  
    8. FEI for Conveyance & Conveyance Companies

      1. The FEI number is always assigned to the company responsible for the condition of the conveyance, service area, watering point, catering point, etc.
      2. An FEI number will be assigned to each facility or terminal owned or operated by a conveyance company. The catering points, watering points and service areas at these terminals/facilities will have the same FEI as the terminal/conveyance company.
      3. Conveyances inspected while in operation will use the FEI of the departure point. (Exception: for vessels use FEI of home port).
      4. Conveyances inspected at a terminal owned by someone else will have the FEI of the home office of the conveyance company. The home office of a conveyance company will never have an establishment type of "Q" for corporate headquarters. It must be coded as "F" for conveyance company. The terminal will have its own FEI to cover inspections of the watering points, service areas etc.
    9.  
    10. Merging of Duplicate FEIs.

      Previously, under the FIS system, duplicate firms could be deleted. In FACTS, there is no delete mechanism. Duplicate FEIs will need to be merged into one file. Merging files must be done with great care to ensure that all data associated with the both FEIs remain. Care must be taken in assuring that registration data and history data are not lost. One should normally merge a newer (larger) number into the older (smaller) number, thus retaining all the historical data. FEI numbers cannot be reused; therefore, once the file has been merged, the merged number cannot be restored and is no longer available for use.

      When it is found that one or more duplicate FEIs have been issued for the same establishment, the following steps should be taken:

      1. District management will decide which FEI to keep and which to merge. The actual merge function is performed by a person with the OEI Coordinator role.
      2. The duplicate(s) will be merged. Once a file is merged, it can not be brought back. If an error has occurred, the only way to restore the data would be to generate a new FEI and reenter all the data that had been merged.
      3. Documentation shall be maintained indicating the following information: date of change and the FEI that was changed.
      4. The establishment jackets for the merged FEIs are combined with the jackets of the retained FEI. In the event of a corporate merger, districts will decide which FEI to keep based on the guidelines listed above.
      5. District personnel should review the combined file to determine if any data from the merged FEI needs to be added/updated to the OEI record of the retained FEI.




 

Appendix V

Establishment Types
(sorted by title)

 

CODE TITLE DEFINITION
AP Accredited Person An accredited third party 510k reviewer, or auditor, as defined in Part 523 of the Act, who, as an employee of Accredited Person Firm (AZ), conducts independent Medical Device inspections in lieu of inspections by FDA. Inspections conducted by an AP are recognized as qualifying inspections.

FDA will audit Accredited Persons on a periodic and “for cause” basis. The AP auditors must continue to demonstrate technical competency in order to maintain accreditation.

Requires only a two-character Industry Code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
AZ Accredited Person Firm MDUFMA An Accredited Person (AP) Firm as defined by MDUFMA is an independent organization not owned or controlled by a manufacturer, supplier, or vendor of articles regulated under the act and has no organizational, material, or financial affiliation (including a consultative affiliation) with such a manufacturer, supplier, or vendor. AP Firms employ auditors (or Accredited Persons) who conduct independent Medical Device inspections in lieu of inspections by FDA. Inspections conducted by an AP are recognized as qualifying inspections.

FDA will inspect the AP Firm facilities to assure they have maintained records and are operating in accordance with procedures as specified in their application and section 704(g)(7) of the Act. FDA will audit AP Firms and auditors on a periodic and “for cause” basis. The AP auditors must continue to demonstrate technical competency in order to maintain accreditation.

Profile Required: No
Registration Required: No
MA Acidified Food Processor Firm which manufactures/produces acidified food products as outlined in 21 CFR 114.

Requires a 5-character process/product code under Inspected Processes & Conclusion section and a 7-character product code on the Products Covered section of the Maintain Inspection Results screen.

Profile Required: No
Registration Required: Acidified Food, BT Food
I Assembler Person or establishment responsible for assembling, replacing, or installing X-Ray components (radiological health only).

Requires full product coding in both the Inspected Processes & Conclusions and Products Covered sections of the FACTS Maintain Inspection Results screen (Page 1).

Profile Required: No
Registration Required: No
RC American Red Cross A national, regional, headquarter facility, testing laboratory, or donor center owned or operated by the American Red Cross. These establishments collect, process, or control the collection and process of blood and blood products.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: Biologics
# Biopharmaceutics Analytical Facility A facility involved in the analytical laboratory testing of human biological specimens for levels of test drug contents or the in vitro testing of test drugs to establish equivalency to a defined stan­dard such as by dissolution testing methods. These facilities may be inte­grated with or completely separate from bio­pharmaceutics clinical facilities (e.g., serving as an independent contractor or part of an analytical chemistry branch of the sponsor).

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
2 Biopharmaceutics Clinical Facility A facility involved in the screening and/or dosing of human subjects for the purpose of obtaining biological specimens (e.g., blood, saliva, urine, feces) for analysis of test drug content to define absorption, distribu­tion, metabolism and/or elimination charac­teristics of the test drug or establish its equivalency to a defined standard.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
B Blood Bank An establishment that collects and processes blood and blood products (Biologics only).

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: Biologics
J Caterer/Catering Point An establishment which prepares complete or partial meals or drinks from raw or partially processed materials for service to passengers or crew aboard an interstate conveyance or for consumption by these groups at a location other than where prepared.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: BT Food
CM Certifier Domestic MDR Registered manufacturers responsible for submission of the annual certification of the number of MDR reports submitted. Per 21 CFR Part 803, MDR.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: Devices
@ Certified Shellfish Establishment (including Depuration Plants) These are establishments that are covered on the Interstate Certified Shellfish Shippers List by either the States or FDA. If a Certified Shellfish establishment also does traditional processing activities such as breading, glazing, etc., the establishment should also be coded as M-Manufacturer.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: BT Food
7 Clinical Investigator/ Animal Clinical Investigator A person who conducts a research study (i.e., administers the test substance to human or animal subjects or uses a device, etc., on the subjects).

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
4 Commercial Sponsor-Monitor A person or facility which initiates, supports and usually monitors an investigational study on FDA regulated products but who does not actually conduct the study.

Requires only a two-character Industry Code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No products Covered reporting is required.

Profile Required: No
Registration Required: No
K Commissary An establishment which supplies raw food products, some dry goods, drinks, etc., which are to receive further processing once placed aboard an interstate conveyance.

Requires only a two-character Industry Code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No products Covered reporting is required.

Profile Required: No
Registration Required: BT Food
Z Component Manufacturer Limited to the manufacture of parts used in the manufacture, by another firm, of medical device or radiological health products. Includes establishments which sell components or parts to the user level.

Requires full product coding in both the Inspected Processes & Conclusions and Products Covered sections of the FACTS Maintain Inspection Results screen (Page 1).

Profile Required: No
Registration Required: No
H Construction (Conveyances, Support Facilities Components) Includes manufacturers of major components which are used for water, food and waste on Interstate conveyances: manufacturers, builders or refurbishers of facilities while the facilities are under construction.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
1 Contract Research Organization A person or establishment who assumes one or more of the obligations of a sponsor as an independent contractor with the sponsor.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
0 (Zero) Contract Sterilizer Performs sterilization or irradiation of products or components of products (including foods) regulated by FDA. The establishments performing this function on device, drug or biological products should be registered with the appropriate center or centers.

Requires full product coding in both the Inspected Processes & Conclusions and Products Covered sections of the FACTS Maintain Inspection Results screen (Page 1).

Profile Required: Yes
Registration Required: Vet Med, Devices, BT Food
C Control Laboratory Performs production quality control work related to products regulated by FDA such as foods, drugs, cosmetics, devices, veterinary drugs, etc. Sterilizers and establishments doing irradiation shall be reported as Contract Sterilizers. The drug and biologic control laboratories must register with FDA.

Requires full product coding in both the Inspected Processes & Conclusions and Products Covered sections of the FACTS Maintain Inspection Results screen (Page 1).

Profile Required: Yes
Registration Required: Biologics, Drugs
F Conveyance Company Transportation companies, buses, airlines, railways and vessels.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
Q Corporate Headquarters (Non-Manufacturing office) The home office or other non-manufacturing office of an establishment which may be visited to obtain records, to handle recalls, obtain food additives, NDA or other data. The location is not normally scheduled for routine inspection.

Requires only a two-character Industry Code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
D Dealer/Retailer An establishment that sells products directly to the public with no product manipulation. Note: Includes manufacturers of custom devices not covered by IDEs for direct sale to and use by the consumer. In addition, includes food establishments whose primary business is retail on premises and doing less than $1,000,000 in wholesale, mail order, and/or internet sales annually.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
MX Device Refurbisher Establishments that restore used devices to the original manufacturer’s operating specification. Establishments that refurbish used devices that the firm originally manufactured are included. Refurbishers are not subject to the GMP regulations.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
UF Device User Facility Hospitals, ambulatory surgical facilities, nursing homes, and outpatient diagnostic and treatment facilities that are not physician’s offices. Per 21 CFR Part 803, MDR.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
DC Donor Center A registered establishment (fixed location) where generally only collections of blood occurs. Does not include establishments affiliated with the American Red Cross.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: Biologics
EF Entry Filer A firm which files Customs entries (manually or electronically) with FDA data for FDA-regulated import entries. May be a Customhouse Broker or a “self-filing” importer.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
G Grower Firms which produce full size fish ready for consumption, Raises livestock, raw agricultural products or aquaculture products for sale (farms, feedlots, dairy farms and botanicals). Note: Includes farms and feedlots mixing medicated feeds, whether or not a 1900 is required, and not holding the feed for sale.

If the Industry code is 69 – Medicated Animal Feeds, full product coding is required in both the Inspected Processes & Conclusions and Products Covered sections of the FACTS Maintain Inspection Results screen (Page 1).

Profile Required: No
Registration Required: Vet Med
HT Human Tissue Establishment An establishment that engages in the recovery, screening, testing, processing, storage, and/or distribution of human tissue intended for transplantation.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: Yes
Registration Required: Biologics Human Tissue
HR Human Tissue Reproductive Establishment An establishment that engages in the recovery, screening, testing, processing, storage and/or distribution of human reproductive tissue.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: Yes
Registration Required: Biologics Human Tissue
HS Human Tissue Stem Cell Establishment (HS) An establishment that engages in the recovery, screening, testing, processing, storage and/or distribution of human stem cells.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: Yes
Registration Required: Biologics Human Tissue
RO Human Tissue Establishment engaged in recovery operations (RO) An establishment that engages in the recovery of human tissue.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: Yes
Registration Required: Biologics Human Tissue
A Importer/Broker A non-customs house firm which acts as a middleman between producers/manufacturers and further distributors, whether the product is of foreign origin (“importer”) or domestic origin (“brokers”).

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
8 Institutional Review Committee (IRC) for Human Studies The IRC/IRB reviews protocols for studies and evaluates patient consent and risk/benefit decisions made regarding study procedures. The IRC may or may not be affiliated with an institution (i.e., hospital, etc.).

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
Y Label/Relabeler An establishment which affixes the original labeling to a product or changes in any way the labeling on a product without affecting the product or its container.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: Yes
Registration Required: Drugs, Vet Med, Devices, BT Food (foreign firms)
ML Low Acid Canned Processor Firm which manufactures/produces low acid canned products as outlined in 21 CFR 113.

Requires a 5-character process/product code under Inspected Processes & Conclusion section and a 7-character product code on the Products Covered section of the Maintain Inspection Results screen.

Profile Required: No
Registration Required: LACF, BT Food
E Mammography Facility A hospital, outpatient department, clinic, radiology practice, mobile unit, office of a physician, or other facility as determined by the Secretary, that conducts breast cancer screening or diagnosis through mammography activities (a radiographic image of the breast). Excludes facilities of the Department of Veterans Affairs.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
M Manufacturer Makes a new or a changed product from one or more ingredients.

Requires full product coding in both the Inspected Processes & Conclusions and Products Covered sections of the FACTS Maintain Inspection Results screen (Page 1).

Profile Required: Yes
Registration Required: Biologics, Drugs, Vet Med, Devices, BT Food
MG Medical Gas Manufacturer Establishments that manufacture or manipulate compressed or liquefied medical gases (includes air liquefaction plants) by filling the product into high pressure cylinders or cryogenic vessels on site or vehicle mounted.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: Yes
Registration Required: Drugs
T Methadone Clinic (and other drug abuse treatment programs) Licensed clinics for methadone maintenance programs.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
6 Monitor (Non-Sponsor)/ Investigator-Monitor A monitor guides the conduct of a study and evaluates study data for a sponsor. An investigator-monitor has the responsibilities of a monitor but also conducts studies and has the responsibility of an investigator.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
9 Non-Clinical Laboratories The firm conducts short and long term studies, using animal subjects, on the safety and func­tionality of products (includes toxicological laboratories).

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
L Own Label Distributor Distributes a product under a custom or own label. The product is manufactured and labeled by another establishment.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
3 Plasmapheresis Center An establishment in which blood is removed from the donor, the plasma is separated from the formed elements, and at least the red blood cells are returned to the donor.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: Biologics
P Public Food Service Restaurants, cafeterias, food vending machine locations and other establishments preparing and selling food directly to the public. Note: Only use for retail food protection programs.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
MR Remanufacturers Establishments that rebuild used devices to new operating specifications that may affect the safety or effectiveness of the device. Establishments that rebuild used devices that the firm originally manufactured are included. Remanufacturers are subject to the GMP regulation.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: Yes
Registration Required: Devices
R Repacker/Packer The establishment packs a product or products into different containers without making any change in the form of the product. Includes packers of raw agricultural products.

Requires full product coding in both the Inspected Processes & Conclusions and Products Covered sections of the FACTS Maintain Inspection Results screen (Page 1).

Profile Required: Yes
Registration Required: Drugs, Vet Med, Devices, BT Food
MB Reprocessor This type of establishment performs remanufacturing operations on a single-use device. A profile is required and device registration is required.

Requires full product coding in both the Inspected Processes & Conclusions mand Products Covered sections of the FACTS Maintain Inspection Results screen (Page 1).

Profile Required: Yes
Registration Required: Devices
X Salvage Operation The retailers, wholesalers, repackers, and underwriters who deal primarily in the resale and reconditioning of damaged goods. Note: Shellfish depuration plants are to be included under the Certified Shellfish Establishment type.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: BT Food if salvaged goods are used for animal feed
*(Asterisk) Seafood Harvesting Vessel/Ship This establishment includes all commercial vessels/ships that harvest seafood products without processing and do not sell product directly to the public. If the vessel/ship processes the product in any manner, (deheading, gutting, scaling, filleting, glazing, etc), then it should be coded as M - Manufacturer. Icing is not considered processing.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
V Service Area All of the facilities within one general area, owned and operated by a single company, used for the removal and disposal of waste materials from conveyances. Cleaning of conveyances may also be performed at these areas.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
S Shipper The establishment responsible for introducing a product or products into interstate commerce. This establishment type is used only for those establishments that have no other responsibility for a product such as manufacture, storage or repacking. Note: Certified Shellfish Shippers are now classified under the Certified Shellfish Establishment type.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
MW Software Manufacturer Establishments that manufacture software for a stand alone medical device or for use in blood establishments.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: Yes
Registration Required: Devices
5 Sponsor/Investigator A person (physician, dentist, etc.) who initiates, supports and conducts alone or with others, an investigational study using regulated products. This person has the responsibilities of both a sponsor and an investigator.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
W Warehouse NOTE: This Establishment Type Code is no longer a valid code for use, but remains present in the database until it can be converted to its appropriate two character code – WA, WF, WR, or WZ. A private or public facility for the storage of consumer products or the reshipment of products from the producer or grower to the manufacturer or other consumer. Included would be domestic distributors of medical devices and diagnostic products who are now required to register with FDA. This can be temporary storage such as cream stations, the tradi­tional warehouse, or grain elevator storing human food.

Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required.

Profile Required: No
Registration Required: No
WA Warehouse-Ambient Storage A private or public facility A private or public facility that holds/stores consumer products at ambient air temperatures (approximately 21 C /70 F) only. Examples are traditional warehouse, grain elevator storing human food; domestic distributors of medical devices and diagnostic products who are required to register with FDA.

The establishment type does not require process/product coding under the Inspected Processes & Conclusion or Products Covered section of the Maintain Inspection Results screen, EXCEPT – Any seafood related activities require product coding on the Inspected Processes & Conclusion section.

Profile Required: No
Registration Required: BT Food, Devices
WZ Warehouse-Ambient, Refrigerated, and Frozen Storage A private or public facility that has three separate areas within the facility to hold/store any consumer products based on the required temperature range of the product being held (ambient, refrigerated or frozen storage). Example – the facility can hold frozen raw fish; pasteurized crabmeat; and canned fish at the appropriate temperatures all at one facility.

The establishment type does not require process/product coding under the Inspected Processes & Conclusion or Products Covered section of the Maintain Inspection Results screen, EXCEPT – Any seafood related activities require product coding on the Inspected Processes & Conclusion section.

Profile Required: No
Registration Required: BT Food
WF Warehouse-Frozen Storage A private or public facility that holds/stores consumer products at frozen temperatures (approximately 0 C/32F or below) only. Examples are facilities storing frozen raw seafood; frozen fruits or vegetables products, etc.

The establishment type does not require process/product coding under the Inspected Processes & Conclusion or Products Covered section of the Maintain Inspection Results screen, EXCEPT – Any seafood related activities require product coding on the Inspected Processes & Conclusion section.

Profile Required: No
Registration Required: BT Food
WR Warehouse-Refrigerated Storage A private or public facility that holds/stores consumer products at refrigerated temperatures (approximately 4C/40F – 0C/32 F) only. Examples are vegetables, fruits; raw seafood; or food where refrigeration is used as a barrier to additional microbial growth; domestic distributors of medical devices and diagnostic products. This can be temporary storage such as cream stations. Domestic distributors of medical devices and diagnostic products are required to register with FDA.

The establishment type does not require process/product coding under the Inspected Processes & Conclusion or Products Covered section of the Maintain Inspection Results screen, EXCEPT – Any seafood related activities require product coding on the Inspected Processes & Conclusion section

Profile Required: No
Registration Required: BT Food, Devices
U Watering Point All of the facilities within one general area, owned and operated by a single company, used as the source of potable water by conveyances in interstate traffic. Requires only a two-character Industry code in the Inspected Processes & Conclusions section of the FACTS Maintain Inspection Results screen (Page 1). No Products Covered reporting is required. Profile Required: No Registration Required: No


Establishment Type

(sorted by Code)

 

CODE TITLE
A
Importer/Broker
AP
Accredited Person
AZ
Accredited Person Firm MDUFMA
B
Blood Banks
C
Control Laboratory
CM
Certifier Domestic MDR
D
Dealer/Retailer
DC
Donor Center
E
Mammography Facility
EF
Entry Filer
F
Conveyance Company
G
Grower
H
Construction (Conveyances, Support Facilities Components)
HT
Human Tissue Establishment
HR
Human Tissue Reproductive Establishment
HS
Human Tissue Stem Cell Establishment
I
Assembler
J
Caterers/Catering Points
K
Commissary
L
Own Label Distributor
M
Manufacturer
MA
Acidified Food Processor
MB
Reprocessor
MG
Medical Gas Manufacturers
ML
Low Acid Canned Processor
MR
Remanufacturers
MW
Software Manufacturer
MX
Device Refurbisher
P
Public Food Service
Q
Corporate Headquarters (Non-Manufacturing Office)
R
Repacker/Packer
RC
American Red Cross
RO
Human Tissue Establishment engaged in recovery operations
S
Shipper
T
Methadone Clinics (and other drug abuse treatment programs)
U
Watering Point
UF
Device User Facility
V
Service Area
W
Warehouse
WA
Warehouse-Ambient Storage
WF
Warehouse-Frozen Storage
WR
Warehouse-Refrigerated Storage
WZ
Warehouse-Ambient, Refrigerated, and Frozen Storage
X
Salvage Operation
Y
Labeler/Relabeler
Z
Component Manufacturers
0 (Zero)
Contract Sterilizer
1
Contract Research Organization
2
Biopharmaceutics Clinical Facility
3
Plasmapheresis Center
4
Commercial Sponsor-Monitor
5
Sponsor-Investigator
6
Monitor (non-sponsor)/Investigator-monitor
7
Clinical Investigator/Animal Clinical Investigator
8
Institutional Review Committee (IRC) for Human Studies
9
Nonclinical Laboratories
#
Biopharmaceutics Analytical Facility
@
Certified Shellfish Establishment
*(Asterisk)
Seafood Harvesting Vessel/Ships




 

Appendix VI

Industry Codes

 

02 Whole Grain/Milled Grain Prod/Starch
03 Bakery Prod/Dough/Mix/Icing
04 Macaroni/Noodle Prod
05 Cereal Prep/Breakfast Food
07 Snack Food Item
09 Milk/Butter/Dried Milk Prod
12 Cheese/Cheese Prod
13 Ice Cream Prod
14 Filled Milk/Imit Milk Prod
15 Egg/Egg Prod
16 Fishery/Seafood Prod
17 Meat, Meat Products and Poultry
18 Vegetable Protein Prod
20 Fruit/Fruit Prod
21 Fruit/Fruit Prod
22 Fruit/Fruit Prod
23 Nuts/Edible Seed
24 Vegetables/Vegetable Products
25 Vegetables/Vegetable Products
26 Vegetable Oils
27 Dressing/Condiment
28 Spices, Flavors And Salts
29 Soft Drink/Water
30 Beverage Bases/Conc/Nectar
31 Coffee/Tea
32 Alcoholic Beverage
33 Candy W/O Choc/Special/Chew Gum
34 Choc/Cocoa Prod
35 Gelatin/Rennet/Pudding Mix/Pie Filling
36 Food Sweeteners (Nutritive)
37 Mult Food Dinner/Grav/Sauce/Special
38 Soup
39 Prep Salad Prod
40 Baby Food Prod
41 Dietary Conv Food/Meal Replacements
45 Food Additives (Human Use)
46 Food Additive (Human Use)
47 Multiple Food Warehouses
50 Color Additive Food/Drug/Cosmetic
51 Food Service/Conveyance
52 Miscellaneous Food Related Items
53 Cosmetics
54 Vit/Min/Prot/Unconv Diet(Human/Animal)
55 Pharm Necess & Ctnr For Drug/Bio
56 Antibiotics (Human/Animal)
57 Bio & Licensed In-Vivo & In-Vitro Diag
59 Multiple Drug Warehouses
60 Human and Animal Drugs
61 Human and Animal Drugs
62 Human and Animal Drugs
63 Human and Animal Drugs
64 Human and Animal Drugs
65 Human and Animal Drugs
66 Human and Animal Drugs
67 Type A Medicated Articles
68 Animal Devices and Diagnostic Products
69 Medicated Animal Feeds
70 Animal Feed(Non-Medicated)
71 Byproducts For Animal Foods
72 Pet/Laboratory Animal Food
73 Anesthesiology
74 Cardiovascular
75 Chemistry
76 Dental
77 Ear, Nose and Throat
78 Gastroenterological & Urological
79 General & Plastic Surgery
80 General Hospital/Personal Use
81 Hematology
82 Immunology
83 Microbiology
84 Neurological
85 Obstetrical & Gynecological
86 Ophthalmic
87 Orthopedic
88 Pathology
89 Physical Medicine
90 Radiological
91 Toxicology
94 Ionizing Non-Medical Devices and Components
95 Light Emitting Non-Device Products
96 Radio Frequency Emitting Products
97 Sound Emitting Products
99 Bio/Anim Drug/Feed&Food/Med Dev/Rh Whse