Wenzhou Ouhai Changhong Glasses Manufacturing Co.,Ltd
✅ Low Risk
FEI: 3003949200 • Wenzhou • CHINA
FEI Number
3003949200
Location
Wenzhou
Country
CHINAAddress
51 Jinda Road, Qianhua Ind. Zone, Wenzhou, , China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/21/2016 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/5/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Los Angeles District Office (LOS-DO) | |
| 10/3/2008 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 6/5/2003 | 86HQZFRAME, SPECTACLE | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Wenzhou Ouhai Changhong Glasses Manufacturing Co.,Ltd's FDA import refusal history?
Wenzhou Ouhai Changhong Glasses Manufacturing Co.,Ltd (FEI: 3003949200) has 4 FDA import refusal record(s) in our database, spanning from 6/5/2003 to 4/21/2016.
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 Ouhai Changhong Glasses Manufacturing Co.,Ltd's FEI number is 3003949200.
What types of violations has Wenzhou Ouhai Changhong Glasses Manufacturing Co.,Ltd received?
Wenzhou Ouhai Changhong Glasses Manufacturing 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 Wenzhou Ouhai Changhong Glasses Manufacturing Co.,Ltd come from?
All FDA import refusal data for Wenzhou Ouhai Changhong Glasses Manufacturing 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.