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FDA establishment 3027021147, 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: 126
Inspections
0 inspections, newest first
FDA has posted no inspections for this site.
Import Refusals
126 refused shipment lines since 2024, grouped by product and charges
Product
Charges
Latest
NICOTINE DELIVERY PRODUCT, NECTobacco · 98NCA99
Tobacco product without a marketing orderTobacco product not reported to FDA
Oct 23, 2026
NICOTINE POUCHTobacco · 98NCA11
Tobacco product without a marketing orderTobacco product not reported to FDA
Oct 22, 202635 lines
SNUSTobacco · 98CCA06
Tobacco product without a marketing orderTobacco product not reported to FDA
Oct 1, 20263 lines
NICOTINE POUCHTobacco · 98NBA11
Tobacco product without a marketing order
Sep 18, 20263 lines
SNUSTobacco · 98CBA06
Tobacco product without a marketing orderTobacco product not reported to FDA
Sep 14, 20262 lines
COMPONENT OR PART OF SNUFFTobacco · 98PCA03
Tobacco product without a marketing orderTobacco product not reported to FDA
Jul 24, 20263 lines
NICOTINE POUCHTobacco · 98NCA11
Tobacco product without a marketing order
Jul 20, 20269 lines
SNUSTobacco · 98CAA06
Tobacco product without a marketing orderTobacco product not reported to FDA
Jul 14, 2026
NICOTINE POUCHTobacco · 98NCA11
Tobacco product without a marketing orderTobacco product not reported to FDATobacco label lacks "sale only allowed in the U.S."
Jun 24, 202634 lines
NICOTINE POUCHTobacco · 98NBA11
Tobacco product without a marketing orderTobacco product not reported to FDA
May 18, 20267 lines
NICOTINE POUCHTobacco · 98NBA11
Tobacco product without a marketing orderTobacco product not reported to FDATobacco label lacks "sale only allowed in the U.S."
Apr 23, 20267 lines
NICOTINE POUCHTobacco · 98NCA11
Tobacco product without a marketing orderTobacco label lacks "sale only allowed in the U.S."
Apr 22, 20263 lines
NICOTINE POUCHTobacco · 98NCA11
Tobacco label lacks "sale only allowed in the U.S."
Feb 21, 20266 lines
NICOTINE POUCHTobacco · 98NCA11
Tobacco product without a marketing orderTobacco product not reported to FDATPLACKFIRMTobacco label lacks "sale only allowed in the U.S."
Sep 26, 20254 lines
NICOTINE POUCHTobacco · 98NCA11
TP FLAVORTobacco product without a marketing orderTobacco label lacks "sale only allowed in the U.S."
Aug 22, 20252 lines
SMOKELESS TOBACCO POUCHESTobacco · 98CCA16
TP FLAVORTobacco product without a marketing orderTobacco label lacks "sale only allowed in the U.S."
Aug 21, 2025
NICOTINE POUCHTobacco · 98NCA11
Tobacco product without a marketing orderTPLACKFIRMTobacco label lacks "sale only allowed in the U.S."
Aug 20, 2025
NICOTINE POUCHTobacco · 98NDA11
Tobacco product without a marketing orderTobacco product not reported to FDA
Jul 23, 20252 lines
NICOTINE POUCHTobacco · 98NDA11
Tobacco product without a marketing order
Jun 24, 2025
NICOTINE POUCHTobacco · 98NBA11
Tobacco product without a marketing orderTPLACKFIRMTobacco label lacks "sale only allowed in the U.S."
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. 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 and warning letters
Sweden. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.