Genn Shang Industry Co
✅ Low Risk
FEI: 3003416497 • Tainan • TAIWAN
FEI Number
3003416497
Location
Tainan
Country
TAIWANAddress
Po Box 45 Ma Tou Chen, , Tainan, , Taiwan
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 |
|---|---|---|---|
| 5/21/2002 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Genn Shang Industry Co's FDA import refusal history?
Genn Shang Industry Co (FEI: 3003416497) has 1 FDA import refusal record(s) in our database, spanning from 5/21/2002 to 5/21/2002.
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. Genn Shang Industry Co's FEI number is 3003416497.
What types of violations has Genn Shang Industry Co received?
Genn Shang Industry Co 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 Genn Shang Industry Co come from?
All FDA import refusal data for Genn Shang Industry Co 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.