Wenzhou N & A Foreign Trade Corp.
⚠️ Moderate Risk
FEI: 3004115027 • Wenzhou, Zhejiang • CHINA
FEI Number
3004115027
Location
Wenzhou, Zhejiang
Country
CHINAAddress
International Trade Centre, 8 Liming Xi Road, 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
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
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.
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.
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 |
|---|---|---|---|
| 6/7/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 231LENS CERT | New Orleans District Office (NOL-DO) |
| 8/17/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New England District Office (NWE-DO) | |
| 6/26/2015 | 86HOISPECTACLE, MAGNIFYING | Division of Southeast Imports (DSEI) | |
| 5/22/2015 | 86HOISPECTACLE, MAGNIFYING | Division of Southeast Imports (DSEI) | |
| 5/5/2015 | 86HOISPECTACLE, MAGNIFYING | 126FAILS STD | Los Angeles District Office (LOS-DO) |
| 5/5/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 126FAILS STD | Los Angeles District Office (LOS-DO) |
| 1/14/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Los Angeles District Office (LOS-DO) |
| 8/11/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Wenzhou N & A Foreign Trade Corp.'s FDA import refusal history?
Wenzhou N & A Foreign Trade Corp. (FEI: 3004115027) has 8 FDA import refusal record(s) in our database, spanning from 8/11/2014 to 6/7/2016.
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 N & A Foreign Trade Corp.'s FEI number is 3004115027.
What types of violations has Wenzhou N & A Foreign Trade Corp. received?
Wenzhou N & A Foreign Trade Corp. has been cited for 6 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 N & A Foreign Trade Corp. come from?
All FDA import refusal data for Wenzhou N & A Foreign Trade Corp. 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.