EPD INTERNATIONAL S.R.O.
⚠️ High Risk
FEI: 3030018731 • Teplice, Ustecky • CZECH REPUBLIC
FEI Number
3030018731
Location
Teplice, Ustecky
Country
CZECH REPUBLICAddress
Zavodni 3206/3361, , Teplice, Ustecky, Czech Republic
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/3/2025 | 98NCA11NICOTINE POUCH | 3842TP NO PMTA | 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) | |
| 6/11/2025 | 98NCA11NICOTINE POUCH | Division of Southeast Imports (DSEI) | |
| 5/28/2025 | 98NCA11NICOTINE POUCH | 3842TP NO PMTA | Division of Southeast Imports (DSEI) |
| 5/23/2025 | 98NCA99NICOTINE DELIVERY PRODUCT, NEC | Division of Southeast Imports (DSEI) | |
| 5/23/2025 | 98NCA99NICOTINE DELIVERY PRODUCT, NEC | Division of Southeast Imports (DSEI) | |
| 5/23/2025 | 98NCA99NICOTINE DELIVERY PRODUCT, NEC | Division of Southeast Imports (DSEI) | |
| 5/23/2025 | 98NCA99NICOTINE DELIVERY PRODUCT, NEC | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is EPD INTERNATIONAL S.R.O.'s FDA import refusal history?
EPD INTERNATIONAL S.R.O. (FEI: 3030018731) has 9 FDA import refusal record(s) in our database, spanning from 5/23/2025 to 7/3/2025.
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. EPD INTERNATIONAL S.R.O.'s FEI number is 3030018731.
What types of violations has EPD INTERNATIONAL S.R.O. received?
EPD INTERNATIONAL S.R.O. has been cited for 3 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 EPD INTERNATIONAL S.R.O. come from?
All FDA import refusal data for EPD INTERNATIONAL S.R.O. 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.