Zhejiang Yiwu China Small
⚠️ Moderate Risk
FEI: 3003793857 • 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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/21/2012 | 64JCY99GAS, MEDICINAL N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 11/8/2005 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/14/2005 | 80FPFBOTTLE, HOT/COLD WATER | Chicago District Office (CHI-DO) | |
| 6/14/2005 | 80FPFBOTTLE, HOT/COLD WATER | Chicago District Office (CHI-DO) | |
| 6/14/2005 | 80KGXTAPE AND BANDAGE, ADHESIVE | Chicago District Office (CHI-DO) | |
| 6/14/2005 | 80KGXTAPE AND BANDAGE, ADHESIVE | Chicago District Office (CHI-DO) | |
| 7/20/2004 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Baltimore District Office (BLT-DO) |
| 2/12/2004 | 76EFWTOOTHBRUSH, MANUAL | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Zhejiang Yiwu China Small's FDA import refusal history?
Zhejiang Yiwu China Small (FEI: 3003793857) has 8 FDA import refusal record(s) in our database, spanning from 2/12/2004 to 2/21/2012.
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. Zhejiang Yiwu China Small's FEI number is 3003793857.
What types of violations has Zhejiang Yiwu China Small received?
Zhejiang Yiwu China Small 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 Zhejiang Yiwu China Small come from?
All FDA import refusal data for Zhejiang Yiwu China Small 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.