Yiwu Foreign Economic Relations & Trade Co., Ltd.
⚠️ Moderate Risk
FEI: 3004079909 • Zhejiang • CHINA
FEI Number
3004079909
Location
Zhejiang
Country
CHINAAddress
No. 643 Chouzhou Road, Yiwu, , 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
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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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 |
|---|---|---|---|
| 2/6/2007 | 86NICLENS, CONTACT, FOR READING DISCOMFORT | San Francisco District Office (SAN-DO) | |
| 3/14/2005 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | Minneapolis District Office (MIN-DO) |
| 3/14/2005 | 76JESFLOSS, DENTAL | 118NOT LISTED | Minneapolis District Office (MIN-DO) |
| 2/28/2005 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 198COLOR LBLG | Los Angeles District Office (LOS-DO) |
| 2/28/2005 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | Los Angeles District Office (LOS-DO) |
| 2/28/2005 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 10/4/2004 | 76EFWTOOTHBRUSH, MANUAL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Yiwu Foreign Economic Relations & Trade Co., Ltd.'s FDA import refusal history?
Yiwu Foreign Economic Relations & Trade Co., Ltd. (FEI: 3004079909) has 7 FDA import refusal record(s) in our database, spanning from 10/4/2004 to 2/6/2007.
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. Yiwu Foreign Economic Relations & Trade Co., Ltd.'s FEI number is 3004079909.
What types of violations has Yiwu Foreign Economic Relations & Trade Co., Ltd. received?
Yiwu Foreign Economic Relations & Trade Co., Ltd. has been cited for 5 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 Yiwu Foreign Economic Relations & Trade Co., Ltd. come from?
All FDA import refusal data for Yiwu Foreign Economic Relations & Trade 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.