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Troubleshooting: facility compliance records and the owner checks

3PL add-on For: Administrator, Compliance manager, Warehouse staff Checked on 18.0.0.2.0, 18.0.1.0.0

What to do when a transfer of an owner's stock is refused by the owner, counterparty and facility checks, or when an FDA annual report, a facility event, the gate log or the facility client list doesn't behave as expected. Entries are ordered from the most frequent.

Related entries on other pages:

Error: "… can't be validated: it moves DSCSA products … to or from a trading partner."​

What you see: an Invalid Operation dialog when you select Validate on a receipt, delivery or return of an owner's stock:

TRANSFER can't be validated: it moves DSCSA products (PRODUCTS) to or from a trading partner.
PROBLEM-LINE
PROBLEM-LINE

For example:

WH2/IN/00005 can't be validated: it moves DSCSA products ([DEMO-PTM-25] Prototamol 25 mg Tablets, 30 count) to or from a trading partner.
Facility Albany Annex has no valid 3PL licence: record our state 3PL licence for it (activity Third-party logistics) and verify it.

When you validate several transfers together, the dialog has one such block per refused transfer.

When: validating a transfer held for an owner that moves DSCSA products to or from a trading partner, in Get an owner transfer through the owner, counterparty and facility checks.

Cause: at least one check failed. Each line below the first names one problem: a line starting "Owner:" is the owner, a line starting "Facility" is your own facility, any other line is the other party (the supplier, customer or return designee).

Remedy: resolution. Fix each line with the entry that matches it:

Then select Validate again. The refused attempt stays in the gate log (Review the gate log).

Who can fix it: mostly an Rx Tracking Manager (licenses, facility records, policies). An Rx Tracking User can correct the transfer's partner and validate again.

Error: "… (ROLE) has no valid …" (the other party)​

What you see: a line of the refusal that names the supplier, the customer or the return designee, for example:

Granite State Rx Supply LLC (wholesaler) has no valid state license: license DEMO-NH-WHL-3301 expired on 2026-09-07.

The text after the name is the core rule's reason: "none on file", "license NUMBER is unverified", "… expired on DATE", "… is not in force until DATE", or a missing role.

When: validating an owner transfer (3PL-FAC-05).

Cause: the other party is not an authorized trading partner today, and the owner's policy is to block (the default).

Remedy: resolution, one of:

  1. Record or verify the partner's license: Record and verify a trading partner's license. The reasons are explained in Troubleshooting: master data.
  2. If the transfer names the wrong partner, correct Receive From (or the delivery address).
  3. Your procedure decides whether an owner's counterparty that fails is let through with a warning: an administrator sets Owner counterparties (Choose the company's 3PL policies), or a manager records the owner's counterparty attestation (Set the owner's policies).

Then select Validate again.

Who can fix it: Rx Tracking Manager (licenses, attestation); Administrator (Administration: Settings) with Rx Tracking Manager for the policy.

Error: "Owner: … has no valid …"​

What you see: a line of the refusal that starts with "Owner:", for example:

Owner: Summit Specialty Pharma Inc. (wholesaler) has no valid FDA 503(e) annual report: none on file.

When: validating an owner transfer (3PL-FAC-05).

Cause: the owner itself is not an authorized trading partner for its DSCSA role. This always refuses, whatever the counterparty policy. The FDA 503(e) reason above appears only while the company's 503(e) setting is on.

Remedy: resolution. Follow The owner is not an authorized trading partner: record or verify the owner's license (Check whether an owner is an authorized trading partner), then select Validate again. For the 503(e) reason, see Error: "… has no valid FDA 503(e) annual report: …".

Who can fix it: Rx Tracking Manager.

Error: "Facility … has no valid 3PL licence …"​

What you see: a line of the refusal, one of:

Facility WAREHOUSE has no valid 3PL licence: record our state 3PL licence for it (activity Third-party logistics) and verify it.
Facility WAREHOUSE has no valid wholesale distributor licence: record our state wholesale licence for it (activity Wholesale distribution) and verify it.

When: validating an owner transfer at that warehouse (3PL-FAC-05). In the example database, any owner receipt at the Albany Annex is refused this way: its New York 3PL license expired and the renewal isn't verified.

Cause: your company has no valid license of the needed activity for that warehouse. An owner of type Owner (3PL client) needs Third-party logistics; a Consignor needs Wholesale distribution. A license doesn't count when it is unverified, expired, not yet in force, archived, of type NABP accreditation, or when its Facility or Activity is empty or different.

Remedy: resolution. Record and verify the license for that warehouse and activity (Record and verify our facility licenses); for a renewal, verify the new license. Then select Validate again. In a state that doesn't license 3PLs, see Record that a state does not license 3PLs.

Who can fix it: Rx Tracking Manager.

Error: "… does not license 3PLs, so the report stands in for the state licence."​

What you see:

Facility WAREHOUSE has no valid FDA annual report record as a 3PL (§584(b)): STATE does not license 3PLs, so the report stands in for the state licence.

For example "Facility Albany Annex has no valid FDA annual report record as a 3PL (§584(b)): New York (US) does not license 3PLs, so the report stands in for the state licence."

When: validating an owner transfer at a warehouse with no valid 3PL license, whose state has a verified jurisdiction record with Does Not License 3PLs (3PL-FAC-05).

Cause: in such a state, a submitted FDA annual report stands in for the state license, and the facility has none that is valid today: none of capacity Third-party logistics provider (§584(b)) or Both, not yet submitted, archived, or past its Valid Until date.

Remedy: resolution. Record and submit the facility's report (Record a facility's FDA annual report and mark it submitted), then select Validate again. If the state does license 3PLs, record your license instead and archive the jurisdiction record.

Who can fix it: Rx Tracking Manager.

Error: "… which the company's 503(e) setting requires."​

What you see:

Facility WAREHOUSE has no valid FDA annual report record as a CAPACITY for DATE, which the company's 503(e) setting requires.

CAPACITY is "3PL" or "wholesale distributor", for example "Facility Albany Annex has no valid FDA annual report record as a 3PL for 2026-09-27, which the company's 503(e) setting requires." The owner may be refused on the same dialog for its own 503(e) report (Error: "Owner: … has no valid …").

When: validating an owner transfer while Wholesalers/3PLs need a 503(e) report is on (3PL-FAC-05).

Cause: with that setting on, each facility also needs a submitted FDA annual report, valid today, whose capacity covers the activity.

Remedy: resolution. Record and submit the report of that capacity, or Both (3PL-FAC-01), then select Validate again. Whether the setting is on is the administrator's choice (Set whether wholesalers and 3PLs need an FDA 503(e) report).

Who can fix it: Rx Tracking Manager (the report); Administrator (Administration: Settings) for the setting.

Error: "… but no trading partner is set on the transfer."​

What you see:

TRANSFER can't be validated: it moves DSCSA products (PRODUCTS) to or from a trading partner, but no trading partner is set on the transfer.

When: validating an owner receipt or delivery without a partner (3PL-FAC-05).

Cause: the transfer comes from or goes to a partner location, but Receive From (or the delivery address) is empty, so there is no party to check. The refusal is logged for the owner.

Remedy: resolution. Fill in Receive From (or the delivery address), save, and select Validate again. Your own transfers show the core message: see Error: "… but no trading partner is set on the transfer.".

Who can fix it: Rx Tracking User or Manager.

Error: "… is not at one of our facilities, so our licence for it can't be checked."​

What you see:

REFERENCE is not at one of our facilities, so our licence for it can't be checked.

This text is quoted from the software; it is not shown in the example database.

When: an owner operation whose record has no warehouse, for example a title transfer or an owner order whose locations belong to no warehouse.

Cause: the facility check needs the warehouse the units are in, and it found none.

Remedy: resolution. Use an operation type or a location that belongs to one of your warehouses, then repeat the action.

Who can fix it: Rx Tracking User or Manager; an administrator for the warehouse and location setup.

Warning: "Trading-partner check for owner … let through with a warning"​

What you see: the transfer validates, and its chatter logs:

Trading-partner check for owner OWNER let through with a warning:
PARTNER (ROLE) has no valid …
Let through: the counterparty check for this owner is set to warn (Q3-02).

The gate log has a Warning row with the same detail. In the example database: Summit's receipt from Crestline Wholesale Drug Co., whose license is unverified.

When: validating an owner transfer whose other party fails while the owner's policy is to warn.

Cause: the company's Owner counterparties setting is Warn, or the owner has a counterparty attestation and Warn only for owners with a recorded counterparty attestation is selected. The code at the end of "Let through: the counterparty check for this owner is set to warn (Q3-02)." refers to the developer's internal list of design questions: it stands for that policy (known issue PF-A05-06).

Remedy: none is needed for the transfer. Your procedure decides what follows a warning, for example asking the partner for its license and recording it (Record and verify a trading partner's license).

Who can fix it: Rx Tracking Manager (the partner's license); Administrator for the policy.

Error: "Enter the submission date and FDA's confirmation of … before marking it submitted."​

What you see: an Invalid Operation dialog:

Enter the submission date and FDA's confirmation of FDA annual report YEAR, FACILITY (CAPACITY) before marking it submitted.

An import of a submitted report without them is refused with "A submitted FDA annual report needs its submission date and FDA's confirmation.".

When: selecting Mark submitted in Record a facility's FDA annual report.

Cause: Submitted On or FDA Confirmation is empty.

Remedy: resolution. Select Close, fill in both fields under Submission, and select Mark submitted again.

Who can fix it: Rx Tracking Manager.

Error: "Enter the reporting year of the FDA annual report (e.g. 2026)."​

What you see: an error dialog when you save the report:

Enter the reporting year of the FDA annual report (e.g. 2026).

When: saving a report in 3PL-FAC-01.

Cause: Reporting Year is outside 2000–2999. The field shows the year with a thousands separator (2,026, known issue PF-W22-01), which the field accepts; the year itself must be four digits.

Remedy: resolution. Select Stay here, enter the year (for example 2026) in Reporting Year and save again.

Who can fix it: Rx Tracking Manager.

Error: "Only DSCSA managers can mark …"​

What you see: one of:

Only DSCSA managers can mark an FDA annual report submitted.
Only DSCSA managers can mark a facility event reported.

In the forms an Rx Tracking User doesn't see New, Mark submitted or Mark reported; selecting Archive in the ⚙ (Actions) menu ends with an Access Error ("You are not allowed to modify …").

When: an Rx Tracking User tries to record, submit, report or archive (3PL-FAC-01, 3PL-FAC-04), or an import does so.

Cause: FDA annual reports and facility events are recorded and closed by Rx Tracking Managers only; users read them and print the summary.

Remedy: resolution. Ask an Rx Tracking Manager to do it.

Who can fix it: Rx Tracking Manager; an administrator grants the right (Settings ‣ Users & Companies ‣ Users, Access Rights tab).

Error: "… is already submitted." or "… is already reported."​

What you see:

FDA annual report YEAR, FACILITY (CAPACITY) is already submitted.
EVENT, FACILITY (DATE) is already reported.

When: Mark submitted or Mark reported on a record that another user (or another browser tab) closed in the meantime.

Cause: the record was submitted or reported already.

Remedy: none needed. Reload the page (press F5) to see the record's current status.

Who can fix it: nobody needs to.

Error: "… is submitted: its … can't change. Archive it and record a new report."​

What you see: the facts of a submitted report are read-only in the form. An import or integration that changes them is refused with one of:

FDA annual report YEAR, FACILITY (CAPACITY) is submitted: its FIELDS can't change. Archive it and record a new report.
A submitted FDA annual report can't go back to draft: archive it and record a new one.
An FDA annual report is recorded as a draft and submitted with the "Mark submitted" button.
An FDA annual report is submitted with the "Mark submitted" button: its status and submitter can't be written directly.
Submitted FDA annual reports are evidence and are never deleted (REPORTS): archive them instead.

When: correcting a submitted report (3PL-FAC-01), or importing reports with a status.

Cause: a submitted report is evidence: its Facility, Reporting Year, Capacity, Submitted On, FDA Confirmation and Trade Names can't change, it can't go back to Draft, and it is never deleted. Only Mark submitted sets the status. No group has the delete right, so a deletion is refused by the access rights first, also for a draft (known issue PF-W22-02).

Remedy: resolution. Archive the wrong report (⚙ (Actions) ‣ Archive) and record a new one (Correct a submitted report). Import new reports as drafts, then submit them in the form.

Who can fix it: Rx Tracking Manager.

Error: "Enter the date the FDA report was updated and FDA's confirmation for … before marking it reported."​

What you see: an Invalid Operation dialog:

Enter the date the FDA report was updated and FDA's confirmation for EVENT, FACILITY (DATE) before marking it reported.

An import of a reported event without them is refused with "A reported facility event needs the report date and FDA's confirmation.".

When: selecting Mark reported in Record a facility event and mark it reported to FDA.

Cause: Reported to FDA On or FDA Confirmation is empty.

Remedy: resolution. Select Close, fill in both fields under Report to FDA, and select Mark reported again.

Who can fix it: Rx Tracking Manager.

Error: "… is not a licence of the facility …"​

What you see: an error dialog when you save an event:

LICENSE is not a licence of the facility FACILITY.

For example "CA State license DEMO-CA-3PL-00917 is not a licence of the facility Albany Annex."

When: saving an event in 3PL-FAC-04.

Cause: the Licence names another warehouse in its Facility. The Licence list offers only the selected facility's licenses, but a license chosen before Facility was changed stays on the form.

Remedy: resolution. Select Stay here, then choose a license of the event's facility in Licence, or clear it, and save again.

Who can fix it: Rx Tracking Manager.

Error: "… is reported: its … can't change. Archive it and record a new event."​

What you see: the facts of a reported event are read-only in the form. An import or integration that changes them is refused with one of:

EVENT, FACILITY (DATE) is reported: its FIELDS can't change. Archive it and record a new event.
A reported facility event can't be reopened: archive it and record a new one.
A facility event is recorded as "To report" and closed with the "Mark reported" button.
A facility event is closed with the "Mark reported" button: its status and recorder can't be written directly.
Facility events are evidence and are never deleted: archive a wrong one instead.

When: correcting a reported event (3PL-FAC-04), or importing events with a status.

Cause: a reported event is evidence: its Facility, Event, Date, Licence, Reported to FDA On and FDA Confirmation can't change and it can't be reopened. No event is ever deleted. Only Mark reported sets the status.

Remedy: resolution. Archive the wrong event (⚙ (Actions) ‣ Archive) and record a new one. The description stays editable.

Who can fix it: Rx Tracking Manager.

There is no FDA annual report reminder​

What you see: no FDA annual report due activity under the clock icon (Activities), and no draft report for the year, although the facility must report.

When: Act on the FDA annual report reminders.

Cause: one of:

  • the scheduled action DSCSA 3PL: FDA annual report reminders hasn't run since the facility became reportable, or it is inactive;
  • 3PL is off for the company;
  • the facility has nothing that makes it report: no facility license of ours of type State license or Federal 3PL licence (future) with an Activity (not expired before 1 January), and no active owner profile that names it in Facilities Served during the year;
  • a submitted report of the year already covers what the facility must report;
  • you aren't an active internal user with the Rx Tracking Manager right and access to the company. Rx Tracking Users never get these reminders.

Remedy: resolution. Fix the cause. To run the job now, an administrator activates the developer mode, goes to Settings ‣ Technical ‣ Scheduled Actions, opens DSCSA 3PL: FDA annual report reminders and selects Run Manually. Or record the report directly (3PL-FAC-01).

Who can fix it: Administrator (Administration: Settings) for the scheduled action; Rx Tracking Manager for licenses and profiles.

The FDA annual report reminder is overdue the day it appears​

What you see: a new FDA annual report due activity, due 31 March of the current year, already shown as overdue.

When: the reminder job runs after 31 March for a facility whose report of the year is missing (3PL-FAC-02).

Cause: the reminder is always due 31 March, and the job runs all year. For a facility that became reportable after 31 March (its first license or owner), the date has already passed (known issue PF-A05-08).

Remedy: workaround. Treat the date as the job's default. Your procedure decides when the facility reports; record the report when it is filed (3PL-FAC-01), which closes the reminders.

Who can fix it: Rx Tracking Manager.

Error: "… no longer exists (its operation was refused and rolled back)."​

What you see: after Open Record on a gate log row, one of:

REFERENCE no longer exists (its operation was refused and rolled back).
This check names no record that can be opened.

These texts are quoted from the software; they are not shown in the example database.

When: Review the gate log.

Cause: the refused operation had created the record it checked, and the refusal undid it. The gate log row stays, with the reference and the detail, but the record is gone.

Remedy: none needed. Read the row's detail; search for the operation by its reference if it was created again.

Who can fix it: nobody needs to.

Error: "The gate log is a record of checks made …"​

What you see: an import or integration that changes or deletes a gate log row is refused with:

The gate log is a record of checks made: its rows can't be changed.
The gate log is a record of checks made: its rows are never deleted.

A call to the export without rows gives "Select the gate log rows to export.". In the list, rows can't be edited or deleted, and Export CSV shows only while rows are selected.

When: Review the gate log and export it.

Cause: gate log rows are written by the software only, and never change.

Remedy: none needed. To give rows to someone, select them and use Export CSV.

Who can fix it: nobody needs to.

The facility client list misses an owner, or lists one it shouldn't​

What you see: an owner you served on the date is not in the Facility Client List, or an owner appears for a date when it didn't use that warehouse.

When: Print or export the facility client list.

Cause: one of:

  • the profile doesn't name the facility in Facilities Served (the window's warning lists active profiles that name no facility);
  • Service Start is after the date, or Service End before it;
  • the profile is archived without a Service End, so it counts as ended;
  • Facilities Served was changed since the date: the list follows today's value (known issue PF-A05-07).

Remedy: resolution for the first three: correct the owner profile (Create an owner profile; an ended relationship: Change, end or re-open an owner relationship). Workaround for the last: explain the change with the list, and print the lists you need before changing Facilities Served.

Who can fix it: Rx Tracking Manager.