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Back to DWPERadar Supplier & Charge Code HubCBP Port Defense • DWPE & Form 766 • Verified 2026-11-13

FDA Import Alert DWPE (Red vs. Green List) & Form FDA 766 Bonded Relabeling Timeline

Regulatory Bottom Line (BLUF)

Once an overseas supplier lands on an FDA Import Alert Red List (DWPE), CBP automatically detains every future entry without physically sampling it first—shifting full testing and compliance proof onto the importer. Form FDA 766 authorizes bonded relabeling ONLY for correctable technical labeling violations (such as § 403(q) nutrition panels or non-compliant claims); pathogen, filth, or insanitary violations (SALMONELLA, LISTERIA, FILTH) require private lab testing under strict protocols or result in export/destruction.

Intelligence vs. Legal Counsel Boundary: Form FDA 766 outcomes depend solely on FDA District Import Compliance Officer approval of your specific reconditioning proposal. DWPERadar benchmarks statutory eligibility based on charge codes and connects importers with licensed US FDA counsel—never file customs responses based solely on automated summaries.

2026 Compliance Matrix & Detention Boundaries

Control Area2026 Rule / StandardPort Detention TriggerExclusion / Verification Limit
Labeling & Nutrition Deficiencies (`NUTRITIONAL_LABELING`, `MISBRANDING`)Apply via Form FDA 766 for permission to relabel/over-sticker under Customs Bond (FTZ or bonded warehouse).Unauthorized sticker tampering before FDA grants Form 766 triggers liquidated damages against your customs bond.FDA requires itemized relabeling SOPs and before/after photographic verification upon completion.
Microbial, Filth & GMP Adulteration (`SALMONELLA`, `FILTH`, `INSANITARY_CONDITIONS`)Relabeling cannot cure product adulteration; Red List DWPE petitions normally require consecutive clean entries verified by private FDA-accredited labs plus root-cause CAPA.Port storage demurrage compounds daily if importers wait too long before electing export/destruction vs testing.Reconditioning is rarely approved for pathogen/filth refusals without validated heat-kill or processing evidence approved in advance.
View dietary-supplements Watchlist →View spices-botanicals Watchlist →View seafood-aquaculture Watchlist →NUTRITIONAL_LABELING Playbook SALMONELLA Playbook FILTH Playbook INSANITARY_CONDITIONS Playbook

2026 Regulatory FAQ

How does a supplier get placed on DWPE vs. the Green List?

Repeat OASIS import refusals or severe inspection Warning Letters lead FDA divisions to add a foreign firm (by FEI) to an Import Alert Red List (DWPE). Green List exemptions exist only for specific firms that submit multi-shipment private lab packages and CAPA evidence approved by FDA DIO.

Can Form FDA 766 clear a SALMONELLA or FILTH detention?

No. Form FDA 766 applies to relabeling or sorting/reconditioning where FDA agrees the defect can be reliably corrected. Pathogen contamination (SALMONELLA/LISTERIA) and filth adulteration generally result in Notice of Refusal of Admission requiring exportation or supervised destruction within 90 days.