The ORA Data Exchange (DX) provides its regulatory partners secured inspection data sharing capabilities via both ORA Partners Portal (ORAPP) and System-to-System Services. The ORA DX systems allow a participating regulatory partner to electronically submit contracted and non-contracted inspection outcomes related to food, animal feed, and other inspections. These systems also allow viewing inspection history of a firm via the firm inventory data sharing capabilities.
Contracted Inspections (CI)
The CI data sharing capability allows a participating regulatory partner to seamlessly and in near-real time submit FDA contracted inspection outcomes including attachments to FDA via System-to-System Services without leaving the state’s inspection management system. This capability eliminates dual data entry for investigators by allowing state users to complete inspection report locally in their system(s). The System-to-System services integration automatically sends the inspection results from the state system to the FDA eSAF system via system agnostic FDA provided data exchange semantics.
CI data sharing capabilities include:
- Submission of CI data related to the following inspection types
- Current Good Manufacturing Practice (CGMP)
- Bovine spongiform encephalopathy (BSE) ("mad cow disease") Checklist
- Seafood Hazard Analysis Critical Control Point (HACCP)
- Food Defense Plan Quick Check (FDPQC) inspection protocol
- Submission of CI related documents/attachments
- Each document size can be up to 250 MB
- One inspection outcome submitted at a time
- Updates to firm inventory tied to the CI outcomes
- Updates to previously submitted CI outcomes
Non-Contracted Inspections (NCI)
The NCI data sharing capability allows a participating regulatory partner to submit state inspection outcomes via ORA Partners Portal (ORAPP) and System-to-System Services. This capability was developed to support the FDA’s mutual reliance initiative and recognize accomplishment of a state’s full conformance to Manufactured Food Regulatory Program Standards (MFRPS). MFRPS compliant states can submit state inspection outcomes to meet FDA’s inspection goals. FDA intends to use this data to meet the Food Safety and Modernization Act (FSMA) mandates and the cover-by-dates in addition to supporting the work planning activities. This data sharing impacts the FDA state contract work planning.
The NCI data sharing capability allows a participating regulatory partner to submit state inspection outcomes via ORA Partners Portal (ORAPP) and System-to-System Services. This capability was developed to support the FDA’s mutual reliance initiative and recognize accomplishment of a state’s full conformance to Manufactured Food Regulatory Program Standards (MFRPS). MFRPS compliant states can submit state inspection outcomes to meet FDA’s inspection goals. FDA intends to use this data to meet the Food Safety and Modernization Act (FSMA) mandates and the cover-by-dates in addition to supporting the work planning activities. This data sharing impacts the FDA state contract work planning.
NCI data sharing activities include:
- Submission of NCI data related to No Action Indicated (NAI) and Non-High Risk (NHR) via FDA provided standardized template
- Allowing up to 500 inspection outcomes submission at a time via ORAPP
- Allowing an inspection outcome submission at a time via System-to-System
NCI data sharing activities do NOT include:
- Updates to firm inventory related to the inspection outcomes submitted to FDA
- Updates to previously submitted inspection outcomes
- Submission of NCI related documents/attachments
Inspection and Inventory Workgroup (WG)
The Inspection and Inventory Workgroup (WG) provides a structured and collaborative platform to support participating regulatory partners for inspection and inventory data sharing via System-to-System.
The Inspection and Inventory WG meets bi-monthly, on the 3rd Tuesday of the month. For more information on how to participate, contact us via the Contact Us page.
