Wehzhou Hieasy Import & Export Company Limited
⚠️ Moderate Risk
FEI: 3008478498 • Wenzhou, Zhejiang • CHINA
FEI Number
3008478498
Location
Wenzhou, Zhejiang
Country
CHINAAddress
Room 17c08 E Zhannan Trade Building, , Wenzhou, Zhejiang, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/16/2020 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 1/12/2018 | 86HOISPECTACLE, MAGNIFYING | Division of Southeast Imports (DSEI) | |
| 12/15/2017 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 12/6/2017 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 10/6/2017 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Wehzhou Hieasy Import & Export Company Limited's FDA import refusal history?
Wehzhou Hieasy Import & Export Company Limited (FEI: 3008478498) has 5 FDA import refusal record(s) in our database, spanning from 10/6/2017 to 7/16/2020.
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. Wehzhou Hieasy Import & Export Company Limited's FEI number is 3008478498.
What types of violations has Wehzhou Hieasy Import & Export Company Limited received?
Wehzhou Hieasy Import & Export Company Limited 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 Wehzhou Hieasy Import & Export Company Limited come from?
All FDA import refusal data for Wehzhou Hieasy Import & Export Company Limited 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.