GUANGZHOU HIGHSPOT HOME APPLIANCE CO LTD
⚠️ Moderate Risk
FEI: 3013950341 • Guangzhou City • CHINA
FEI Number
3013950341
Location
Guangzhou City
Country
CHINAAddress
4a26, No. 582, 584, Dashi Section 105 National Way, Dashi Street, , Guangzhou City, , 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 |
|---|---|---|---|
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) | |
| 1/5/2018 | 79LRRKIT, FIRST AID | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is GUANGZHOU HIGHSPOT HOME APPLIANCE CO LTD's FDA import refusal history?
GUANGZHOU HIGHSPOT HOME APPLIANCE CO LTD (FEI: 3013950341) has 21 FDA import refusal record(s) in our database, spanning from 1/5/2018 to 1/5/2018.
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 HIGHSPOT HOME APPLIANCE CO LTD's FEI number is 3013950341.
What types of violations has GUANGZHOU HIGHSPOT HOME APPLIANCE CO LTD received?
GUANGZHOU HIGHSPOT HOME APPLIANCE CO LTD 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 GUANGZHOU HIGHSPOT HOME APPLIANCE CO LTD come from?
All FDA import refusal data for GUANGZHOU HIGHSPOT HOME APPLIANCE 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.