77 POUCHES
🚨 Critical Risk
FEI: 3019293375 • Cracow, Malopolskie • POLAND
FEI Number
3019293375
Location
Cracow, Malopolskie
Country
POLANDAddress
Al. 29 Listopada 94, , Cracow, Malopolskie, Poland
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe violations.
Statistics
Score Breakdown
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
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.
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).
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.
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.
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2025 | 98CAA06SNUS | Division of Southeast Imports (DSEI) | |
| 7/22/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 7/15/2025 | 98NCA11NICOTINE POUCH | 3842TP NO PMTA | Division of Southeast Imports (DSEI) |
| 7/14/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 7/14/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 7/14/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 7/14/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 7/14/2025 | 98NCA11NICOTINE POUCH | 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 | Division of Northeast Imports (DNEI) | |
| 6/26/2025 | 98NCA11NICOTINE POUCH | Division of Northeast Imports (DNEI) | |
| 6/26/2025 | 98NCA11NICOTINE POUCH | Division of Northeast Imports (DNEI) | |
| 6/26/2025 | 98NCA11NICOTINE POUCH | Division of Northeast Imports (DNEI) | |
| 6/20/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 6/20/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 6/12/2025 | 98NCA11NICOTINE POUCH | Division of Northeast Imports (DNEI) | |
| 6/12/2025 | 98NCA11NICOTINE POUCH | Division of Northeast Imports (DNEI) | |
| 6/12/2025 | 98NCA11NICOTINE POUCH | Division of Northeast Imports (DNEI) | |
| 6/5/2025 | 98NCA99NICOTINE DELIVERY PRODUCT, NEC | Division of Northeast Imports (DNEI) | |
| 5/29/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 5/29/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 5/28/2025 | 98NCA99NICOTINE DELIVERY PRODUCT, NEC | 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 | Division of Southeast Imports (DSEI) | |
| 5/8/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 5/6/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 5/6/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 5/6/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 5/6/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 5/2/2025 | 98NCA11NICOTINE POUCH | 3842TP NO PMTA | Division of Southeast Imports (DSEI) |
| 4/24/2025 | 98NDA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 4/24/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 4/24/2025 | 98CCA06SNUS | Division of Southeast Imports (DSEI) | |
| 4/24/2025 | 98CCA06SNUS | Division of Southeast Imports (DSEI) | |
| 4/24/2025 | 98CCA06SNUS | Division of Southeast Imports (DSEI) | |
| 4/24/2025 | 98CCA06SNUS | Division of Southeast Imports (DSEI) | |
| 4/24/2025 | 98CCA06SNUS | Division of Southeast Imports (DSEI) | |
| 4/24/2025 | 98NBA99NICOTINE DELIVERY PRODUCT, NEC | Division of Southeast Imports (DSEI) | |
| 4/22/2025 | 98NCA99NICOTINE DELIVERY PRODUCT, NEC | Division of Southeast Imports (DSEI) | |
| 4/22/2025 | 98NCA99NICOTINE DELIVERY PRODUCT, NEC | Division of Southeast Imports (DSEI) | |
| 4/22/2025 | 98NCA99NICOTINE DELIVERY PRODUCT, NEC | Division of Southeast Imports (DSEI) | |
| 4/22/2025 | 98NCA99NICOTINE DELIVERY PRODUCT, NEC | 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.