Wenzhou Success Group Co., Ltd.
⚠️ Moderate Risk
FEI: 3004521931 • Wenzhou, Zhejiang • CHINA
FEI Number
3004521931
Location
Wenzhou, Zhejiang
Country
CHINAAddress
Success Mansion F 6, Liu Hongqiao Road; Nanjiaoxiang 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
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 |
|---|---|---|---|
| 3/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Cincinnati District Office (CIN-DO) |
| 11/7/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northeast Imports (DNEI) | |
| 10/29/2012 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 9/14/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 9/12/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Los Angeles District Office (LOS-DO) |
| 7/20/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Wenzhou Success Group Co., Ltd.'s FDA import refusal history?
Wenzhou Success Group Co., Ltd. (FEI: 3004521931) has 6 FDA import refusal record(s) in our database, spanning from 7/20/2012 to 3/12/2013.
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. Wenzhou Success Group Co., Ltd.'s FEI number is 3004521931.
What types of violations has Wenzhou Success Group Co., Ltd. received?
Wenzhou Success Group 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 Success Group Co., Ltd. come from?
All FDA import refusal data for Wenzhou Success Group 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.