WENZHOU DONGBO TRADE CORPORATION
⚠️ Moderate Risk
FEI: 3006222953 • Wenzhou, Zhejiang • CHINA
FEI Number
3006222953
Location
Wenzhou, Zhejiang
Country
CHINAAddress
Jinglong Dasha F 21, Nanpu Street Chezhan Avenue; Lucheng, 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
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 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).
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/6/2020 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 8/4/2020 | 86HQZFRAME, SPECTACLE | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 7/27/2020 | 86HQZFRAME, SPECTACLE | Division of Southeast Imports (DSEI) | |
| 7/27/2020 | 86HQZFRAME, SPECTACLE | Division of Southeast Imports (DSEI) | |
| 7/21/2020 | 86HQZFRAME, SPECTACLE | Division of Southeast Imports (DSEI) | |
| 7/8/2020 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 7/8/2020 | 86HOISPECTACLE, MAGNIFYING | Division of Southeast Imports (DSEI) | |
| 6/25/2020 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 6/23/2020 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 6/18/2020 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 6/18/2020 | 86HQZFRAME, SPECTACLE | Division of Southeast Imports (DSEI) | |
| 6/18/2020 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 6/18/2020 | 86HQZFRAME, SPECTACLE | Division of Southeast Imports (DSEI) | |
| 6/18/2020 | 86HOISPECTACLE, MAGNIFYING | Division of Southeast Imports (DSEI) | |
| 6/12/2020 | 86HQZFRAME, SPECTACLE | Division of Southeast Imports (DSEI) | |
| 8/26/2019 | 86HQZFRAME, SPECTACLE | Division of Southeast Imports (DSEI) | |
| 12/29/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 12/20/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 11/17/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 9/1/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 9/1/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 8/18/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 9/8/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Los Angeles District Office (LOS-DO) | |
| 2/1/2011 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is WENZHOU DONGBO TRADE CORPORATION's FDA import refusal history?
WENZHOU DONGBO TRADE CORPORATION (FEI: 3006222953) has 24 FDA import refusal record(s) in our database, spanning from 2/1/2011 to 8/6/2020.
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. WENZHOU DONGBO TRADE CORPORATION's FEI number is 3006222953.
What types of violations has WENZHOU DONGBO TRADE CORPORATION received?
WENZHOU DONGBO TRADE CORPORATION has been cited for 7 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 WENZHOU DONGBO TRADE CORPORATION come from?
All FDA import refusal data for WENZHOU DONGBO TRADE CORPORATION 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.