Weizhong Corp
⚠️ Moderate Risk
FEI: 3005783523 • Dongguan • CHINA
FEI Number
3005783523
Location
Dongguan
Country
CHINAAddress
Qiu Fu Rd Da Lang Town, , Dongguan, , 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).
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 |
|---|---|---|---|
| 9/16/2011 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/24/2009 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/5/2008 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 341REGISTERED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Weizhong Corp's FDA import refusal history?
Weizhong Corp (FEI: 3005783523) has 3 FDA import refusal record(s) in our database, spanning from 12/5/2008 to 9/16/2011.
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. Weizhong Corp's FEI number is 3005783523.
What types of violations has Weizhong Corp received?
Weizhong Corp 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 Weizhong Corp come from?
All FDA import refusal data for Weizhong 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.