Suspect product without Odoo Enterprise
Core module Odoo Enterprise: Quality app 3PL add-on Odoo Community alternative For: Administrator, Compliance manager Checked on 18.0.0.2.0, 18.0.1.0.0
Rx Tracking (DSCSA) - Suspect Product Investigations adds an investigation record, with its deadlines and the Form FDA 3911 data, to Odoo Enterprise's Quality app. On Odoo Community you still hold the suspect lot, find its units and trading partners, gather the records and dispose of the units with the core module; the investigation itself is kept outside the add-on, on the lot and in your own files.
Requires: Rx Tracking (DSCSA). Works in Odoo Community (and in Enterprise, without the Quality app).
Suspect and illegitimate product without Odoo Enterprise
A Community database can't install the add-on: Inventory ‣ Configuration ‣ Settings shows Quality with an Enterprise badge, and activating Rx Tracking (DSCSA) - Suspect Product Investigations installs nothing (Known issue PF-W01-01). See On Odoo Community: the Enterprise add-ons don't install.
What the Enterprise add-on adds
- An investigation record for each suspect lot (Inventory ‣ Rx Tracking ‣ Suspect Investigations), opened by hand or automatically when a lot is quarantined (Investigate suspect product).
- The determination that a product is illegitimate, with the 24-hour notification deadline and the overdue list (Record that the product is illegitimate and start the 24-hour clock, Keep notifications within the 24-hour deadline).
- Find Trading Partners: the companies of the lot's done receipts and deliveries, the partners to notify (Find the trading partners to notify).
- The Form FDA 3911 data sheet, prefilled from the lot, the packages and your company (Complete and print the Form FDA 3911 data sheet).
- The record of the notifications to FDA and to the trading partners, follow-ups, termination requests and closing (Record the notifications, File a follow-up, or request the termination of a notification, Close an investigation).
- With the 3PL add-on, investigations and Form 3911 data per owner (Investigate owners' stock).
What to do instead in Odoo Community
| Step | Community procedure |
|---|---|
| Hold the suspect lot, so it can't be reserved or shipped | Quarantine a lot so it can't be reserved or shipped, then Review the lots on hold, and why they are held and, if you keep a quarantine shelf, Move quarantined stock to a quarantine shelf |
| Keep the running record | the lot itself: its Quarantine Reason, and notes and files in its chatter (Log note, the 📎 (Attach files) icon) |
| Keep the deadline in view | an activity on the lot: in its chatter, select Activities, then in Schedule Activity enter a Summary, the Due Date and Assigned to, and select Schedule. A Due Date is a day, not an hour, so note the time the clock started in the summary |
| Find where the lot's units went | the package ledger: Look up a unit in the package ledger (group the lot's packages by Shipped To); the lot form's Packages, Sales, Transfers and Traceability smart buttons (some under More) |
| Gather the transaction records of the lot | a trace request by lot: Log a trace request, Search the records a trace request asks for and Respond to a trace request with the response zip; for a request from FDA or a partner, Keep trace requests within the 24-hour deadline |
| Notify FDA with Form FDA 3911 | outside Odoo, in FDA's own channel (see Background below). The lot, its packages and the trace request's zip give you the facts to enter; keep a copy of what you filed in the lot's chatter |
| Dispose of the units | Scrap DSCSA units, naming each unit's serial or Send a non-saleable return to the supplier; returned suspect units: Verify returned units for resale, or reject and destroy them |
| Release the lot when it is cleared | Release a lot from quarantine, with the outcome as the release reason |
| A lot that holds owners' units (3PL) | the hold notifies each owner, and the release needs each owner's instruction: Put a lot that holds owner units on hold, Find and read the notices sent to an owner; on the owner's recall instruction, Recall an owner's lots with its consignee list (3PL-HOLD-08) |
A duplicate serial at receipt is held for you by the receipt itself: see Handle a duplicate serial at receipt.
What you don't get without it
- No investigation record: the kind of suspicion, the determination and the outcome live in the lot's chatter and your own files.
- No deadline tracking: no 24-hour deadline computed from the determination and no overdue list; only the activities you schedule yourself.
- No Find Trading Partners list: you build it from the package ledger and the lot's transfers.
- No Form FDA 3911 data sheet or prefill, and no record of the notifications, follow-ups or termination requests.
- No investigation opened automatically when a lot is quarantined.
- With the 3PL add-on: no owner-scoped investigation or Form 3911 data; an owner learns of a hold through its owner notice, and of anything else only from what you send it.
Why it matters
Background: the modules follow the reading that suspect product is quarantined and investigated with trading partners, and released if cleared; that illegitimate product is reported to FDA and to the immediate trading partners that may have received it within 24 hours on Form FDA 3911, through FDA's portal or by email; and that investigation records are kept at least six years after the investigation ends (FD&C Act § 582(c)(4); FDA suspect-product guidance (June 2021); Form FDA 3911; see Compliance background). The investigation and Form 3911 are in the Enterprise add-on and the lot quarantine is in the core module.
Your procedure decides how you investigate, who determines that a product is illegitimate, how you notify FDA and your trading partners, and where you keep the investigation file; on Community the software keeps the lot's hold, its reason and its chatter.