The Office of Regulatory Affairs Data Exchange (ORA DX) provides FDA regulatory partners with the following inventory data sharing capabilities:
- Search and view FDA firms
- Reconcile state and FDA firm inventories
- Share Produce Safety farm inventory with FDA
- Exchange firm information between regulatory partners
Inventory data sharing is intended to assist inspectors, supervisors, and work planning staff to improve efficiency and expedite workflow activities related to the execution of facility inspections and reporting.
FDA Firm Search and Firm History
The ORA DX includes Firm Search and Firm History capabilities that provide regulatory partner (user) access to FDA firm inventory and improve communication between FDA and regulatory partners. These capabilities include:
FDA Firm Search (ORA Partners Portal (ORAPP) and System-to-System Services)
- Search and view FDA firm details such as name, address, firm-FDA Establishment Identifier (FEI), establishment type, operation status, last inspection date, firm aliases, firm registrations, etc.
- Search is limited to firms within the partner’s state for non-Sample users in ORAPP
- Download FDA firm data in XML format (via System-to-System Services) or in Excel format (via ORAPP)
FDA Firm History (ORAPP Only)
- View FDA firm history data e.g., consumer complaints, registrations, and previous inspections via ORAPP
- Print the firm history information
- This feature is unavailable for the Sample users in ORAPP
State to State Firm Search (System-to-System Services Only)
- Share their firm information with other regulatory partners
Produce Safety Farm Inventory
The Produce Safety (PS) Farm Inventory capability in ORAPP supports FDA PS Cooperative Agreement Program (CAP) grantee states to upload produce safety files and receive data to meet produce safety goals. A state grantee enrolled in Program Path A can share detailed inventory information with FDA via the ORAPP capability. A state grantee enrolled in Program Path B or C primarily uses the ORAPP capability for CAP reporting submissions, sharing aggregate inventory data and midyear reports with FDA. The ORAPP capability provides secure and restricted access to files that are relevant to a state.
State agencies, local agencies, and FDA maintain firm inventories for licensing and registration purposes and for tracking inspectional and enforcement activities related to the facilities they regulate. When multiple agencies share jurisdiction over the same facilities, inventory reconciliation helps to ensure consistency among the agencies.
The ORA DX enables FDA and regulatory partners to securely share establishment information (inventory) to support inventory reconciliation activities. This real-time data sharing initiative allows FDA and its partners to rapidly review shared data to improve inventories, assist in work planning activities, increase efficiencies, and aid in timely and accurate regulatory decision making.
The ORA DX currently support inventory reconciliation under the human and animal food programs.
Inventory reconciliation activities include:
- State/Partner submission of establishment information
- State Inventory data can be submitted via an Excel spreadsheet file upload in ORAPP (requires credentials)
- Submission via System-to-System Services will be available soon
- Submitted information is reconciled against FDA inventory
- Reporting of variations for FDA and partner follow-up