- Discrepancy
- 14 dosage units of oxycodone 30mg unaccounted for across the last two count cycles. No matching waste log entries. Access limited to two staff members. No prior discrepancy history at this site.
- Call
- Reportable. Notify the field division office inside the one-business-day window.
- Criterion
- 21 CFR 1301.76(b): notice on discovery of a significant loss, with significance left to the registrant's professional judgment.
Confidence
78%
Escalated for sign-off
The quantity is above this pharmacy's twelve-month variance baseline. Access is concentrated in two people. No waste documentation corroborates the gap. A reportable call brings an inspection either way. It goes to the pharmacist-in-charge to read and sign, not to a queue that files on its own.