Guangzhou Sange Electronic Co Ltd
⚠️ Moderate Risk
FEI: 3007944085 • Haerbin, Heilongjiang • CHINA
FEI Number
3007944085
Location
Haerbin, Heilongjiang
Country
CHINAAddress
Taian Da Street, Daowai District, Haerbin, Heilongjiang, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/6/2010 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 7/8/2010 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 7/8/2010 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Guangzhou Sange Electronic Co Ltd's FDA import refusal history?
Guangzhou Sange Electronic Co Ltd (FEI: 3007944085) has 3 FDA import refusal record(s) in our database, spanning from 7/8/2010 to 8/6/2010.
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. Guangzhou Sange Electronic Co Ltd's FEI number is 3007944085.
What types of violations has Guangzhou Sange Electronic Co Ltd received?
Guangzhou Sange Electronic Co Ltd 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 Guangzhou Sange Electronic Co Ltd come from?
All FDA import refusal data for Guangzhou Sange Electronic 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.