SETAS GROUP AB

FDA establishment 3038461138, Sweden. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.

Inspections: 0
Official action indicated: 0
Last inspection ended: —
Warning letters: 0
Import refusals since 2024: 139

Inspections

0 inspections, newest first

FDA has posted no inspections for this site.

Import Refusals

139 refused shipment lines since 2024, grouped by product and charges

Product	Charges	Latest
NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 20266 lines
NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing orderTobacco product not reported to FDA	Oct 21, 202629 lines
NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing orderTobacco product not reported to FDA	Oct 7, 202663 lines
NICOTINE POUCHTobacco · 98NCA11	Tobacco label lacks "sale only allowed in the U.S."	Sep 25, 20262 lines
NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order	Sep 25, 2026
NICOTINE POUCHTobacco · 98NBA11	Tobacco label lacks "sale only allowed in the U.S."	Sep 25, 2026
NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing orderTobacco product not reported to FDATobacco label lacks "sale only allowed in the U.S."	Sep 21, 202616 lines
NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing orderTobacco product not reported to FDATobacco label lacks "sale only allowed in the U.S."	Sep 21, 20265 lines
NICOTINE POUCHTobacco · 98NCA11	TPLACKFIRM	Jun 2, 202615 lines
NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing orderTobacco product not reported to FDATPLACKFIRMTobacco label lacks "sale only allowed in the U.S."	Apr 17, 2026

Identifiers

FEI number: 3038461138
FDA firm profile: Data Dashboard

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard, warning letters and enforcement reports