Troubleshooting: illegitimate product and Form FDA 3911
Odoo Enterprise: Quality app For: Compliance manager, Warehouse staff Checked on 18.0.0.2.0, 18.0.1.0.0
What to do when the determination, notification or termination dates are refused, when the 24-hour deadline doesn't behave as expected, or when the Form FDA 3911 data sheet is incomplete, in Odoo Enterprise's Quality app with Rx Tracking (DSCSA) - Suspect Product Investigations. Entries are ordered from the most frequent.
The date errors appear when you save, in Odoo's "Oh snap!" dialog with the buttons Stay here (keep your changes and correct them) and
Discard changes (go back to the saved values). INVESTIGATION stands for the investigation's reference, for example QA00009.
Elsewhere:
- The DSCSA fields, tabs or the Form FDA 3911 button aren't shown: see The DSCSA fields and tabs aren't shown.
- Form FDA 3911 items show another lot, or the serials are empty: see Form FDA 3911 items are empty, or show another lot.
- "Form FDA 3911 is only for DSCSA investigations.", "INVESTIGATION: set the lot first." and "Unsupported search on the notification overdue flag." (an import, a script or a custom filter): see Errors when investigations are changed through an import or the API.
- Quarantining or releasing the lot from the investigation: see Troubleshooting: suspect-product investigations.
The banner stays after FDA was recorded as notified
What you see: you saved FDA Notified On, but the yellow banner (or, after the deadline, the red banner and the red row) is still there, and so is the Notify FDA (Form 3911) activity.
When: in Record the notifications to FDA and to the trading partners.
Cause: Trading Partners to Notify lists partners, and Trading Partners Notified On is empty. The deadline is met only when FDA is recorded as notified and, if partners are listed, the partners too.
Remedy: a resolution. Enter Trading Partners Notified On once the listed partners are notified, and save. If a listed partner doesn't need a notification, remove it from Trading Partners to Notify (the × on its tag) and save.
Who can fix it: Rx Tracking User or Manager.
Error: "… is before the determination date."
What you see:
INVESTIGATION: FDA Notified On is before the determination date.
INVESTIGATION: Trading Partners Notified On is before the determination date.
When: saving the DSCSA Investigation tab, in Record the notifications to FDA and to the trading partners, or after moving Determined Illegitimate On later than a recorded notification.
Cause: a notification can't be dated before the determination.
Remedy: a resolution.
- Select Stay here.
- Correct FDA Notified On or Trading Partners Notified On, or, if the determination time is wrong, Determined Illegitimate On.
- Save again.
Who can fix it: Rx Tracking User or Manager.
Error: "… the determination date can't be in the future."
What you see:
INVESTIGATION: the determination date can't be in the future.
When: saving Determined Illegitimate On, in Record that the product is illegitimate and start the 24-hour clock.
Cause: the date and time are more than 5 minutes after now. A common slip is a wrong day or AM/PM, or a time typed in another time zone: the form uses your user's time zone.
Remedy: a resolution. Select Stay here, enter the moment the determination was made, and save again.
Who can fix it: Rx Tracking User or Manager.
Error: "Invalid fields: Determined Illegitimate On"
What you see: a notification at the top right, "Invalid fields:" followed by "Determined Illegitimate On", and the field outlined in red.
When: saving an investigation whose DSCSA Investigation is Illegitimate product, in Record that the product is illegitimate and start the 24-hour clock.
Cause: Determined Illegitimate On was emptied. It is required for an illegitimate product, because the deadline is counted from it.
Remedy: a resolution. Enter the date and time of the determination and save. If the product isn't illegitimate after all, select Suspect product in DSCSA Investigation instead.
Who can fix it: Rx Tracking User or Manager.
Error: "… a termination can only be requested after FDA was notified."
What you see:
INVESTIGATION: a termination can only be requested after FDA was notified.
When: saving Termination Requested On, in File a follow-up, or request the termination of a notification.
Cause: FDA Notified On is empty: there is no recorded notification to terminate.
Remedy: a resolution. Select Stay here, clear Termination Requested On, and save. Record the initial notification first (ILL-04), then request the termination.
Who can fix it: Rx Tracking User or Manager.
Error: "… FDA can only approve a termination on or after the day it was requested."
What you see:
INVESTIGATION: FDA can only approve a termination on or after the day it was requested.
When: saving Termination Approved On, in File a follow-up, or request the termination of a notification.
Cause: Termination Requested On is empty, or Termination Approved On is an earlier day.
Remedy: a resolution. Select Stay here, then enter Termination Requested On (the day the request was sent) or correct Termination Approved On, and save again.
Who can fix it: Rx Tracking User or Manager.
A closed investigation is still overdue
What you see: an investigation in the stage Solved still shows the red banner and the Notify FDA (Form 3911) activity, and it is listed by the Notification Overdue filter once the In Progress facet is removed.
When: after Close an investigation.
Cause: closing doesn't check the notifications. The deadline stays open until the notifications are recorded, whatever the stage.
Remedy: a resolution. Record FDA Notified On and, if partners are listed, Trading Partners Notified On (ILL-04). The fields can be changed on a closed investigation.
Who can fix it: Rx Tracking User or Manager.
Find Trading Partners adds nobody, or isn't shown
What you see: Find Trading Partners isn't on the DSCSA Investigation tab, or selecting it leaves Trading Partners to Notify empty or without a partner you expected.
When: in Find the trading partners to notify.
Cause:
| Symptom | Cause |
|---|---|
| The link isn't shown | The investigation has no Lot |
| Nobody, or not every partner, is added | Only done receipts of the lot from a supplier and done deliveries of it to a customer count. Opening stock, inventory adjustments, open deliveries, customer returns and returns to the supplier don't |
| A partner you removed comes back | Running Find Trading Partners again adds every partner of those transfers |
Remedy: set the Lot on the investigation (a resolution); add missing partners by hand in Trading Partners to Notify, and remove the ones that don't need a notification after the last run (a workaround).
Who can fix it: Rx Tracking User or Manager.
No deadline, banner or activity on an illegitimate product
What you see: the investigation is (or was) an illegitimate product, but it shows no Notification Deadline, no banner, or no Notify FDA (Form 3911) activity.
When: after Record that the product is illegitimate and start the 24-hour clock.
Cause:
| Situation | Cause |
|---|---|
| No banner, no activity, the dates are recorded | The notifications are recorded: the deadline is met, and the activity was marked done |
| No banner and no DSCSA tabs | You have no Rx Tracking right (for example a Quality user in the Quality app): the banners and DSCSA fields are only for Rx Tracking users |
| No DSCSA Investigation tab at all, the record isn't in Suspect Investigations | DSCSA Investigation was cleared: the record is a plain quality alert (the chatter shows the change) |
| DSCSA Investigation is Suspect product | The deadline applies to illegitimate products only |
Remedy: for a cleared or wrong type, select Illegitimate product in DSCSA Investigation again and save (a resolution: the previous determination date comes back, or the current time if there was none). For missing rights, see Give staff access to investigations.
Who can fix it: Rx Tracking User or Manager (rights: Administrator, Administration: Settings).
Items are blank on the Form FDA 3911 data sheet
What you see: the printed data sheet has empty boxes.
When: in Complete and print the Form FDA 3911 data sheet.
Cause:
| Item | Why it is blank |
|---|---|
| 2 (incident number) | FDA Incident Number is empty until FDA's receipt is recorded |
| 3, 6, 8, 18, 20 | Never prefilled: fill them in on the Form FDA 3911 tab |
| 4 (date of initial notification) | FDA Notified On is empty until you record it |
| 19 | Only for a request for termination |
| 21 (address parts) | The company's address is incomplete |
| 23 (D-U-N-S) | The D-U-N-S number setting is empty |
| 24 (telephone, email) | The Contact Person has no phone or email; the company's phone is used when the contact has none |
Remedy: a resolution. Fill in the items on the investigation, the company's address in Settings ‣ Users & Companies ‣ Companies, or the D-U-N-S number (Set up investigations: D-U-N-S number, automatic investigations, Form 3911 data), then print again.
Who can fix it: Rx Tracking User or Manager for the investigation; Administrator (Administration: Settings) with Rx Tracking Manager for the D-U-N-S number and the company.
Type of Report is wrong, or item 19 isn't shown
What you see: Type of Report isn't the type you are about to submit, or Why the Notification Is No Longer Necessary isn't on the Form FDA 3911 tab.
When: in File a follow-up, or request the termination of a notification.
Cause: Type of Report is computed: Initial notification, then Follow-up notification once FDA Incident Number is set, then Request for termination once Termination Requested On is set. Item 19 is shown only for Request for termination (or when it already holds text). A value selected by hand is replaced when one of those two fields changes. On any quality alert whose DSCSA Investigation was chosen after its form opened, new or saved, the type stays empty until one of those two fields is set; only New in Inventory ‣ Rx Tracking ‣ Suspect Investigations fills it (known issue PF-A11-05). The printed data sheet then still ticks Initial notification.
Remedy: a resolution. Enter FDA Incident Number or Termination Requested On as the case requires, or select the type by hand after changing them. For an empty type, select Initial notification by hand (a workaround for PF-A11-05).
Who can fix it: Rx Tracking User or Manager.
The deadline activity names another deadline
What you see: the Notify FDA (Form 3911) activity's note says "Submit Form FDA 3911 and notify the immediate trading partners by DATE-TIME (UTC)." with a time that differs from Notification Deadline on the form.
When: after changing Determined Illegitimate On, in Record that the product is illegitimate and start the 24-hour clock; and always by the time-zone difference.
Cause: the note is written once, when the activity is created, and states the time in UTC; the form shows your local time. When the determination moves, the activity's due date follows but its note doesn't (known issue PF-A11-07).
Remedy: a workaround. Go by Notification Deadline on the form. To have a matching note, edit the activity's note in the chatter (Edit on the activity).
Who can fix it: Rx Tracking User or Manager.
The deadline counted as met although no trading partner was notified
What you see: after only FDA Notified On was recorded, the banner is gone and the chatter says "Notify FDA (Form 3911) done" with "Feedback: FDA and trading partners notified.", although the lot was shipped to customers.
When: in Record the notifications to FDA and to the trading partners.
Cause: Trading Partners to Notify was empty: with no partner listed, the FDA date alone meets the deadline (known issue PF-A11-06).
Remedy: a workaround. Select Find Trading Partners, notify the partners it lists, and record Trading Partners Notified On. Adding partners after the FDA date brings the deadline back (the banner, the red row once it has passed, and a new Notify FDA (Form 3911) activity) until that date is recorded.
Who can fix it: Rx Tracking User or Manager.
Nobody is reminded of an unanswered termination request
What you see: Termination Requested On was recorded weeks ago, Termination Approved On is empty, and nothing points to it: no activity, column or filter.
When: after File a follow-up, or request the termination of a notification.
Cause: the software records the request but schedules nothing (known issue PF-A11-11).
Remedy: a workaround. When you record the request, schedule an activity on the investigation (Activities in the chatter) for the day you expect FDA's answer.
Who can fix it: Rx Tracking User or Manager.