Zhenjiang Wanxin Optical Co., Ltd
⚠️ Moderate Risk
FEI: 3007235871 • Zhenjiang, Jiangsu • CHINA
FEI Number
3007235871
Location
Zhenjiang, Jiangsu
Country
CHINAAddress
No. 25 Guangming Middle Rd, Danyang, Zhenjiang, Jiangsu, 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.
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).
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 |
|---|---|---|---|
| 9/24/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | San Francisco District Office (SAN-DO) | |
| 1/18/2012 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | Cincinnati District Office (CIN-DO) |
| 6/29/2011 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Cincinnati District Office (CIN-DO) |
| 3/17/2011 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | Cincinnati District Office (CIN-DO) |
| 2/24/2011 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 231LENS CERT | New York District Office (NYK-DO) |
| 1/20/2011 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | Cincinnati District Office (CIN-DO) |
| 12/30/2010 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | New York District Office (NYK-DO) | |
| 11/10/2010 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | Seattle District Office (SEA-DO) |
| 5/13/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Los Angeles District Office (LOS-DO) | |
| 3/11/2009 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 235NOT IMPACT | Seattle District Office (SEA-DO) |
| 2/27/2009 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Zhenjiang Wanxin Optical Co., Ltd's FDA import refusal history?
Zhenjiang Wanxin Optical Co., Ltd (FEI: 3007235871) has 11 FDA import refusal record(s) in our database, spanning from 2/27/2009 to 9/24/2012.
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. Zhenjiang Wanxin Optical Co., Ltd's FEI number is 3007235871.
What types of violations has Zhenjiang Wanxin Optical Co., Ltd received?
Zhenjiang Wanxin Optical Co., Ltd 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 Zhenjiang Wanxin Optical Co., Ltd come from?
All FDA import refusal data for Zhenjiang Wanxin 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.