GUANGDONG FEI FAN MSTAR TECHNOLOGY LTD
⚠️ Moderate Risk
FEI: 3016604451 • Foshan, Guangdong • CHINA
FEI Number
3016604451
Location
Foshan, Guangdong
Country
CHINAAddress
A1 Workshop, No.10, Dongnan Xincun Avenue, 2 Caobian No.3 Industrial Zone, Dali; Zone Nanhai District, Foshan, 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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 12/4/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | Division of West Coast Imports (DWCI) | |
| 10/16/2020 | 80QKUNON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS (FFRS) | Division of West Coast Imports (DWCI) | |
| 9/28/2020 | 80MSHRESPIRATOR, SURGICAL | Division of Southeast Imports (DSEI) | |
| 7/23/2020 | 80MSHRESPIRATOR, SURGICAL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 80MSHRESPIRATOR, SURGICAL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/18/2020 | 80MSHRESPIRATOR, SURGICAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GUANGDONG FEI FAN MSTAR TECHNOLOGY LTD's FDA import refusal history?
GUANGDONG FEI FAN MSTAR TECHNOLOGY LTD (FEI: 3016604451) has 7 FDA import refusal record(s) in our database, spanning from 6/18/2020 to 12/4/2020.
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. GUANGDONG FEI FAN MSTAR TECHNOLOGY LTD's FEI number is 3016604451.
What types of violations has GUANGDONG FEI FAN MSTAR TECHNOLOGY LTD received?
GUANGDONG FEI FAN MSTAR TECHNOLOGY LTD has been cited for 5 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 GUANGDONG FEI FAN MSTAR TECHNOLOGY LTD come from?
All FDA import refusal data for GUANGDONG FEI FAN MSTAR TECHNOLOGY 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.