Guangzhou Fortunique Limited
⚠️ Moderate Risk
FEI: 3003915904 • Guangzhou, Guangdong • CHINA
FEI Number
3003915904
Location
Guangzhou, Guangdong
Country
CHINAAddress
Building 4, No. 202 Shiyulu; Fanyu, Guangzhou, Guangdong, 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/22/2018 | 80MMPCOVER, BARRIER, PROTECTIVE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 10/22/2018 | 80MMPCOVER, BARRIER, PROTECTIVE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 10/22/2018 | 80MMPCOVER, BARRIER, PROTECTIVE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 10/22/2018 | 80MMPCOVER, BARRIER, PROTECTIVE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 9/21/2018 | 80MMPCOVER, BARRIER, PROTECTIVE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 9/21/2018 | 80MMPCOVER, BARRIER, PROTECTIVE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 9/21/2018 | 80MMPCOVER, BARRIER, PROTECTIVE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 8/6/2018 | 80MMPCOVER, BARRIER, PROTECTIVE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 8/6/2018 | 80MMPCOVER, BARRIER, PROTECTIVE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 8/6/2018 | 80MMPCOVER, BARRIER, PROTECTIVE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 8/6/2018 | 80MMPCOVER, BARRIER, PROTECTIVE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Guangzhou Fortunique Limited's FDA import refusal history?
Guangzhou Fortunique Limited (FEI: 3003915904) has 11 FDA import refusal record(s) in our database, spanning from 8/6/2018 to 10/22/2018.
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 Fortunique Limited's FEI number is 3003915904.
What types of violations has Guangzhou Fortunique Limited received?
Guangzhou Fortunique Limited 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 Fortunique Limited come from?
All FDA import refusal data for Guangzhou Fortunique Limited 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.