Dongtou Foreign Trade Corporation, Zhejiang
✅ Low Risk
FEI: 3002573173 • Zhan Jiang, Guangdong • CHINA
FEI Number
3002573173
Location
Zhan Jiang, Guangdong
Country
CHINAAddress
No. 242 Hongxin Street, Dongtou, Zhan Jiang, Guangdong, China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Cincinnati District Office (CIN-DO) | |
| 12/11/2002 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | New York District Office (NYK-DO) |
| 12/11/2002 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | New York District Office (NYK-DO) |
| 12/11/2002 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dongtou Foreign Trade Corporation, Zhejiang's FDA import refusal history?
Dongtou Foreign Trade Corporation, Zhejiang (FEI: 3002573173) has 4 FDA import refusal record(s) in our database, spanning from 12/11/2002 to 10/16/2012.
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. Dongtou Foreign Trade Corporation, Zhejiang's FEI number is 3002573173.
What types of violations has Dongtou Foreign Trade Corporation, Zhejiang received?
Dongtou Foreign Trade Corporation, Zhejiang has been cited for 2 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 Dongtou Foreign Trade Corporation, Zhejiang come from?
All FDA import refusal data for Dongtou Foreign Trade Corporation, Zhejiang 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.