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US FDA Import Refusals Explorer

Corpus vintage 2026-10-20 · 210,625 records · span 2016-10-03 to 2026-10-15 · source: FDA Data Dashboard (public)

When a shipment of an FDA-regulated product arrives at a US port and appears to violate the FD&C Act or related statutes, FDA can refuse admission: the goods sit at the dock until they are fixed, re-exported or destroyed. Every refusal decision is public. This explorer turns the full 210,625-record corpus into an instantly scannable picture - use it to vet a supplier before wiring a deposit, or to see which products from your country get stopped and why.

Refusals by month

Most-refused countries

Most-refused firms

Top refusal charge codes

Browse recent refusals

The newest refusals below are searchable - type a supplier name, country or product keyword. The embedded slice covers the most recent 20,243 of 210,625 records (1,999,997-byte payload).

Firms appearing many times are separate entry-line records, each with its own shipment identifier and refusal decision - repetition is the signal, not a join artifact. Sample-analysis columns: F = FDA sample collected and analyzed, P = private lab analysis on file, "-" = neither. Division acronyms are FDA import-office codes: DSEI = Division Of Southeast Imports (Dsei); DNEI = Division Of Northeast Imports (Dnei); DWCI = Division Of West Coast Imports (Dwci); DSWI = Division Of Southwest Imports (Dswi); DNBI = Division Of Northern Border Imports (Dnbi). Full field definitions: FDA Actions & Enforcement.

Frequently asked questions

What does "FDA refusal" mean?

When an entry of an FDA-regulated product (food, drugs, devices, cosmetics, tobacco and more) appears to violate US law at the port of entry, FDA may refuse admission. The shipment cannot be distributed in the US until the violation is corrected or the goods are re-exported or destroyed; see FDA's official actions-and-enforcement overview for the legal basis.

Which country's products are refused most often?

In this dataset of 210,625 refusal records covering 2016-10-03 through 2026-10-15, shipments from India account for 29,224 refusals (13.9% of all records), followed by China (26,443), Sweden (22,385), Mexico (20,062).

Which firms appear most often in FDA refusal records?

Swedish Match Ab leads with 3,807 refusal records, mostly tobacco and nicotine products. Repeated appearances usually trigger an FDA import alert, which puts future shipments from the same firm on detention-without-physical-examination lists - worth checking before you sign a supply contract.

How recent is this data?

The corpus was fetched from FDA's public Data Dashboard on 2026-10-20 and spans refusal decisions dated 2016-10-03 to 2026-10-15. The newest month is marked partial on the chart because the fetch window ends mid-month.

How can exporters avoid a refusal?

Every refusal record carries its regulatory charge code. Match your product against the charges your source country receives most, fix the underlying compliance gap (labeling, registration, prior notice, pesticide limits), and monitor new refusals for your supplier name before each shipment.

Methodology and redistribution terms: Data Sources & Methodology. Figures are informational and not a binding compliance determination; verify with FDA before making shipment decisions.