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77 POUCHES

🚨 Critical Risk

FEI: 3019293375 • Cracow, Malopolskie • POLAND

FEI

FEI Number

3019293375

📍

Location

Cracow, Malopolskie

🇵🇱

Country

POLAND
🏢

Address

Al. 29 Listopada 94, , Cracow, Malopolskie, Poland

Critical Risk

FDA Import Risk Assessment

78.0
LowModerateHighCritical

This firm has an extensive history of FDA import refusals with severe violations.

Statistics

155
Total Refusals
6
Unique Violations
11/20/2025
Latest Refusal
2/27/2023
Earliest Refusal

Score Breakdown

Violation Severity
60.5×40%
Refusal Volume
81.2×30%
Recency
97.3×20%
Frequency
100.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

3842147×

TP NO PMTA

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be adulterated under section 902(6)(A) of the FD&C Act in that it does not have an FDA marketing order in effect under section 910(c)(1)(A)(i) of the FD&C Act.

384364×

TP NO SE

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be misbranded under section 903(a)(6) of the FD&C Act in that a notice or other information respecting it was not provided as required by section 905(j).

385410×

TPLKUSSLLB

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations.

38515×

TPLACKFIRM

This article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(A) of the FD&C Act in that the label does not contain the name and place of business of the tobacco product manufacturer, packer or distributor.

38525×

TPLACKSNC

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(B) of the FD&C Act in that the label does not provide an accurate statement of the quantity of contents in terms of weight, measure or numerical count.

38941×

TPNICWARN

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that appears to be misbranded under section 903(a)(7)(B) in that it is sold or distributed in violation of regulations prescribed under 906(d), namely its package fails to bear the required warning statement "WARNING: This product contains nicotine. Nicotine is an addictive chemical." Or if applicable the required statement "This product is made from tobacco."

Refusal History

DateProductViolationsDivision
11/20/2025
98CAA06SNUS
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
7/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
7/15/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
7/14/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
7/14/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
7/14/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
7/14/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
7/14/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
7/3/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
7/3/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
7/3/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
7/3/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
6/30/2025
98CCA06SNUS
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
6/30/2025
98CCA06SNUS
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
6/30/2025
98CCA06SNUS
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
6/26/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
6/26/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
6/26/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
6/26/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
6/20/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
6/20/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
6/12/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
6/12/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
6/12/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
6/5/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
5/29/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
5/29/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
5/28/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
5/28/2025
98NAA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NAA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NAA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/28/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/8/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
5/8/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
5/6/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
5/6/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
5/6/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
5/6/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
5/2/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/24/2025
98NDA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
4/24/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
4/24/2025
98CCA06SNUS
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
4/24/2025
98CCA06SNUS
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
4/24/2025
98CCA06SNUS
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
4/24/2025
98CCA06SNUS
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
4/24/2025
98CCA06SNUS
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
4/24/2025
98NBA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
4/22/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
4/22/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
4/22/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
4/22/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
4/18/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NAA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NAA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NAA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
4/18/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is 77 POUCHES's FDA import refusal history?

77 POUCHES (FEI: 3019293375) has 155 FDA import refusal record(s) in our database, spanning from 2/27/2023 to 11/20/2025.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. 77 POUCHES's FEI number is 3019293375.

What types of violations has 77 POUCHES received?

77 POUCHES has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about 77 POUCHES come from?

All FDA import refusal data for 77 POUCHES is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.