OPES CORPORATION OY
⚠️ High Risk
FEI: 3037667458 • Kontiolahti • FINLAND
FEI Number
3037667458
Location
Kontiolahti
Country
FINLANDAddress
Kappelikuja 8, , Kontiolahti, , Finland
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/3/2025 | 98EAA02CIGARETTE FILTERS | 3842TP NO PMTA | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is OPES CORPORATION OY's FDA import refusal history?
OPES CORPORATION OY (FEI: 3037667458) has 1 FDA import refusal record(s) in our database, spanning from 7/3/2025 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. OPES CORPORATION OY's FEI number is 3037667458.
What types of violations has OPES CORPORATION OY received?
OPES CORPORATION OY has been cited for 1 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 OPES CORPORATION OY come from?
All FDA import refusal data for OPES CORPORATION OY 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.