Suspect product: Rx Tracking (DSCSA) - Suspect Product Investigations

Investigate suspect product, determine illegitimate product, keep the 24-hour deadline and prepare the Form FDA 3911 data, in Odoo Enterprise's Quality app.

Requires: Odoo Enterprise with the Quality app, and Rx Tracking (DSCSA) - Suspect Product Investigations.

Pages

• Set up suspect-product investigations
  • Set up investigations: D-U-N-S number, automatic investigations, Form 3911 data
  • Give staff access to investigations
  • Use Quality Control checks alongside DSCSA operations
• Investigate suspect product
  • Find and review investigations
  • Open a suspect-product investigation for a lot
  • Follow the investigation a lot quarantine opens automatically
  • Quarantine the lot from its investigation
  • Release the lot from its investigation
• Handle illegitimate product and Form FDA 3911
  • Record that the product is illegitimate and start the 24-hour clock
  • Find the trading partners to notify
  • Complete and print the Form FDA 3911 data sheet
  • Record the notifications to FDA and to the trading partners
  • Keep notifications within the 24-hour deadline
• Follow up and close an investigation
  • File a follow-up, or request the termination of a notification
  • Close an investigation
• Investigation fields, statuses and rules
  • Investigation fields, the Form 3911 item map, types and statuses
  • Who may change an investigation, and every rule that refuses
• Investigate owners' stock
  • What changes for investigations when you hold owners' stock
  • Open an investigation of an owner's units
  • Follow the automatic investigations of a lot that holds owners' units
  • Split an investigation per owner
  • Quarantine and release, from an investigation, a lot that holds owners' units
  • Prepare an owner's trading partners and Form FDA 3911, and hand them to the owner
  • Change the investigated owner
• Suspect product without Odoo Enterprise
  • Suspect and illegitimate product without Odoo Enterprise

When something goes wrong

• Suspect-product investigations
• Illegitimate product and Form FDA 3911

Related guides

• Quarantine and release lots (core)
• Answer trace requests (core)
• 3PL guide