Danyang Foreign Trade Corporation
⚠️ Moderate Risk
FEI: 3003531652 • Danyang City, Jiangsu Province • CHINA
FEI Number
3003531652
Location
Danyang City, Jiangsu Province
Country
CHINAAddress
25 Dong Fang Road, , Danyang City, Jiangsu Province, 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 |
|---|---|---|---|
| 11/6/2006 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 6/10/2005 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 12/14/2004 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Danyang Foreign Trade Corporation's FDA import refusal history?
Danyang Foreign Trade Corporation (FEI: 3003531652) has 3 FDA import refusal record(s) in our database, spanning from 12/14/2004 to 11/6/2006.
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. Danyang Foreign Trade Corporation's FEI number is 3003531652.
What types of violations has Danyang Foreign Trade Corporation received?
Danyang Foreign Trade Corporation 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 Danyang Foreign Trade Corporation come from?
All FDA import refusal data for Danyang Foreign Trade Corporation 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.