Wenzhou Ouhua Foreign Trade Corp.
⚠️ Moderate Risk
FEI: 3002538102 • Wenzhou, Zhejiang • CHINA
FEI Number
3002538102
Location
Wenzhou, Zhejiang
Country
CHINAAddress
Block A F/2, Xiao South Rd; Wuniuzhen Yongjiaxian, 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.
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/11/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Division of Northeast Imports (DNEI) |
| 7/19/2011 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 477HOLES | New York District Office (NYK-DO) |
| 7/19/2011 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 477HOLES | New York District Office (NYK-DO) |
| 4/14/2011 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Los Angeles District Office (LOS-DO) | |
| 9/23/2010 | 86HOISPECTACLE, MAGNIFYING | Los Angeles District Office (LOS-DO) | |
| 9/23/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Los Angeles District Office (LOS-DO) | |
| 9/23/2010 | 86HOISPECTACLE, MAGNIFYING | Los Angeles District Office (LOS-DO) | |
| 9/23/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Wenzhou Ouhua Foreign Trade Corp.'s FDA import refusal history?
Wenzhou Ouhua Foreign Trade Corp. (FEI: 3002538102) has 8 FDA import refusal record(s) in our database, spanning from 9/23/2010 to 4/11/2012.
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 Ouhua Foreign Trade Corp.'s FEI number is 3002538102.
What types of violations has Wenzhou Ouhua Foreign Trade Corp. received?
Wenzhou Ouhua Foreign Trade Corp. has been cited for 4 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 Ouhua Foreign Trade Corp. come from?
All FDA import refusal data for Wenzhou Ouhua 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.