Wenling Dongfangge Decoration Co.,Ltd.
⚠️ Moderate Risk
FEI: 3008046336 • Taizhou, Zhejiang • CHINA
FEI Number
3008046336
Location
Taizhou, Zhejiang
Country
CHINAAddress
NO 85 Houxianlu, Wenling, Taizhou, 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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northeast Imports (DNEI) | |
| 7/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northeast Imports (DNEI) | |
| 7/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northeast Imports (DNEI) | |
| 7/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northeast Imports (DNEI) | |
| 7/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Wenling Dongfangge Decoration Co.,Ltd.'s FDA import refusal history?
Wenling Dongfangge Decoration Co.,Ltd. (FEI: 3008046336) has 5 FDA import refusal record(s) in our database, spanning from 7/12/2013 to 7/12/2013.
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. Wenling Dongfangge Decoration Co.,Ltd.'s FEI number is 3008046336.
What types of violations has Wenling Dongfangge Decoration Co.,Ltd. received?
Wenling Dongfangge Decoration Co.,Ltd. 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 Wenling Dongfangge Decoration Co.,Ltd. come from?
All FDA import refusal data for Wenling Dongfangge Decoration Co.,Ltd. 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.