Wenzhou Light Industrial Products Arts & Crafts I & E Co., L
⚠️ Moderate Risk
FEI: 3003381970 • Wenzhou, Zhejiang • CHINA
FEI Number
3003381970
Location
Wenzhou, Zhejiang
Country
CHINAAddress
Int'l Trade Centre Bldg. F/22, NO. 8 Liming Puzhoucun; 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.
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.
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 |
|---|---|---|---|
| 3/9/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/3/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 8/20/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 231LENS CERT | Seattle District Office (SEA-DO) |
| 9/26/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Wenzhou Light Industrial Products Arts & Crafts I & E Co., L's FDA import refusal history?
Wenzhou Light Industrial Products Arts & Crafts I & E Co., L (FEI: 3003381970) has 4 FDA import refusal record(s) in our database, spanning from 9/26/2012 to 3/9/2018.
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 Light Industrial Products Arts & Crafts I & E Co., L's FEI number is 3003381970.
What types of violations has Wenzhou Light Industrial Products Arts & Crafts I & E Co., L received?
Wenzhou Light Industrial Products Arts & Crafts I & E Co., L 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 Light Industrial Products Arts & Crafts I & E Co., L come from?
All FDA import refusal data for Wenzhou Light Industrial Products Arts & Crafts I & E Co., L 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.