Wenzhou Center Optical Co., Ltd.
⚠️ Moderate Risk
FEI: 1000469032 • Wenzhou, Zhejiang • CHINA
FEI Number
1000469032
Location
Wenzhou, Zhejiang
Country
CHINAAddress
10 Beiwei 1st Rd., Ouhai, 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
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 |
|---|---|---|---|
| 3/22/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/2/2008 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/15/2006 | 86HOISPECTACLE, MAGNIFYING | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 3/15/2006 | 86HOISPECTACLE, MAGNIFYING | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 3/15/2006 | 86HOISPECTACLE, MAGNIFYING | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 3/15/2006 | 86HOISPECTACLE, MAGNIFYING | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 3/15/2006 | 86HOISPECTACLE, MAGNIFYING | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 6/18/2004 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Wenzhou Center Optical Co., Ltd.'s FDA import refusal history?
Wenzhou Center Optical Co., Ltd. (FEI: 1000469032) has 8 FDA import refusal record(s) in our database, spanning from 6/18/2004 to 3/22/2013.
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 Center Optical Co., Ltd.'s FEI number is 1000469032.
What types of violations has Wenzhou Center Optical Co., Ltd. received?
Wenzhou Center Optical 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 Center Optical Co., Ltd. come from?
All FDA import refusal data for Wenzhou Center Optical 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.