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FDA establishment 3030264727, Poland. 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: 591
Inspections
0 inspections, newest first
FDA has posted no inspections for this site.
Import Refusals
591 refused shipment lines since 2024, grouped by product and charges
Product
Charges
Latest
NICOTINE POUCHTobacco · 98NCA11
Tobacco product without a marketing orderTobacco product not reported to FDA
Oct 22, 2026333 lines
NICOTINE DELIVERY PRODUCT, NECTobacco · 98NCA99
Tobacco product without a marketing orderTobacco product not reported to FDA
Oct 13, 2026155 lines
NICOTINE POUCHTobacco · 98NBA11
Tobacco product without a marketing orderTobacco product not reported to FDA
Sep 17, 202630 lines
CHEWING TOBACCO, TWISTTobacco · 98CCA03
Tobacco product without a marketing order
Sep 14, 2026
NICOTINE POUCHTobacco · 98NCA11
Tobacco product without a marketing order
Jul 31, 20268 lines
NICOTINE POUCHTobacco · 98NCA11
Tobacco product without a marketing orderTobacco label lacks "sale only allowed in the U.S."
Jul 21, 20262 lines
NICOTINE POUCHTobacco · 98NCA11
Tobacco product without a marketing orderTobacco product not reported to FDATobacco label lacks "sale only allowed in the U.S."
May 4, 2026
NICOTINE POUCHTobacco · 98NDA11
Tobacco product without a marketing orderTobacco product not reported to FDA
May 1, 20263 lines
NICOTINE DELIVERY PRODUCT, NECTobacco · 98NCA99
Tobacco product without a marketing orderTobacco product not reported to FDATobacco label lacks "sale only allowed in the U.S."TPNICWARN
Jan 29, 20262 lines
NICOTINE DELIVERY PRODUCT, NECTobacco · 98NCA99
Tobacco product without a marketing order
Nov 10, 202530 lines
NICOTINE POUCHTobacco · 98NCA11
TP FLAVOR
Jul 16, 2025
NICOTINE DELIVERY PRODUCT, NECTobacco · 98NCA99
Tobacco product without a marketing orderTobacco product not reported to FDATobacco label lacks "sale only allowed in the U.S."TPNOWRNLBL
May 20, 2025
SNUSTobacco · 98CCA06
Tobacco product without a marketing orderTobacco product not reported to FDA
May 12, 20257 lines
NICOTINE TRANSDERMAL PATCHTobacco · 98NAA01
Tobacco product without a marketing orderTobacco product not reported to FDA
May 2, 2025
NICOTINE DELIVERY SYSTEMDrugs · 66BAY44
Tobacco product without a marketing orderTobacco product not reported to FDA
Apr 28, 2025
NICOTINE DELIVERY PRODUCT, NECTobacco · 98NCA99
TPLACKFIRMTobacco label lacks "sale only allowed in the U.S."
Apr 22, 20256 lines
SNUSTobacco · 98CCA06
Tobacco product without a marketing order
Apr 18, 2025
NICOTINE DELIVERY PRODUCT, NECTobacco · 98NCA99
Tobacco product without a marketing orderTobacco product not reported to FDATobacco label lacks "sale only allowed in the U.S."
Apr 7, 20254 lines
NICOTINE DELIVERY PRODUCT, NECTobacco · 98NDA99
Tobacco product without a marketing orderTobacco product not reported to FDA
Apr 2, 2025
SNUSTobacco · 98CDA06
Tobacco product without a marketing orderTobacco product not reported to FDATobacco label lacks "sale only allowed in the U.S."
Mar 27, 2025
NICOTINE POUCHTobacco · 98NAA11
Tobacco 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