Zhejiang Ouhai International Trade Corp.
✅ Low Risk
FEI: 3002813951 • Wenzhou, Zhejiang • CHINA
FEI Number
3002813951
Location
Wenzhou, Zhejiang
Country
CHINAAddress
No 12 26 Limingzhonglu, , Wenzhou, Zhejiang, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/28/2005 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 9/18/2004 | 76MMDTOOTHBRUSH, IONIC, BATTERY-POWERED | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/3/2001 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Zhejiang Ouhai International Trade Corp.'s FDA import refusal history?
Zhejiang Ouhai International Trade Corp. (FEI: 3002813951) has 3 FDA import refusal record(s) in our database, spanning from 10/3/2001 to 9/28/2005.
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. Zhejiang Ouhai International Trade Corp.'s FEI number is 3002813951.
What types of violations has Zhejiang Ouhai International Trade Corp. received?
Zhejiang Ouhai International Trade Corp. has been cited for 1 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 Zhejiang Ouhai International Trade Corp. come from?
All FDA import refusal data for Zhejiang Ouhai International Trade Corp. 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.