FDA Form 3911 is the notification form trading partners use to report suspect or illegitimate product to the FDA after verification failures, counterfeiting concerns, or other DSCSA-triggered investigations.
Dispensers typically file when VRS verification fails and the product cannot be dispensed. Distributors may file when receiving investigations confirm suspect serials or broken chain-of-custody.
3911 is a compliance workflow—not a traceability transport. EPCIS and VRS provide the serial-level evidence that feeds the investigation leading to a 3911 decision.
In TracePharma
- → Verification and dispense-check workflows log failed GTIN+serial checks with audit trail.
- → Compliance exports include verification history to support 3911 investigations.
- → Exception investigation ties supplier accountability to suspect serial events.
Related terms
Using FDA Form 3911 in daily operations?
See how TracePharma turns standards-based events into receiving, verification, and compliance workflows.