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Inspection Data Sharing

FDA provides its regulatory partners secured information sharing capabilities to electronically submit contracted and non-contracted inspection outcomes related to food, animal feed, and other inspections in support of the national Integrated Food Safety System (IFSS), Partnership for Food Protection (PFP), and FDA’s Mutual Reliance initiatives. Regulatory partners are automatically notified by the system about any data issues without requiring human intervention. The ability to view inspection history of a firm is also available via the firm inventory data sharing capabilities.

Contracted Inspections (CI)

The Contracted Inspections data sharing capability allows regulatory partners to seamlessly submit inspection outcomes in near-real time including attachments to the FDA via ORA DX System-to-System Services without leaving the state’s inspection management system. After completing the system integration activities between the state and FDA systems, this capability eliminates double data entry for investigators by allowing state users to complete their inspection report locally in their systems and automatically send the inspection results to the FDA eSAF system.

Contracted Inspection data sharing capabilities include:

  • Submission of data related to inspection types such as Current Good Manufacturing Practice (CGMP), Bovine spongiform encephalopathy ("mad cow disease") Checklist, and seafood Hazard Analysis Critical Control Point (HACCP) via system agnostic FDA provided data exchange semantics
  • Submission of CI related documents/attachments, each document up to 250 MB size (note: one inspection outcome submitted at a time)
  • Updates to firms tied to the inspection outcomes
  • Updates to previously submitted inspection outcomes

Non-Contracted Inspections (NCI)

The NCI data sharing capability allows regulatory partners 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 Excel template
  • Allowing up to 500 inspection outcomes submission at a time

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