GUANGDONG NAFEI INDUST HOLDING
⚠️ Moderate Risk
FEI: 3016629652 • Guangdong • CHINA
FEI Number
3016629652
Location
Guangdong
Country
CHINAAddress
4th Rd Ecological Tech, , 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.
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.
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 |
|---|---|---|---|
| 4/23/2021 | 80MSHRESPIRATOR, SURGICAL | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/23/2021 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/23/2021 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 3/12/2021 | 80MSHRESPIRATOR, SURGICAL | Division of West Coast Imports (DWCI) | |
| 3/12/2021 | 80MSHRESPIRATOR, SURGICAL | Division of West Coast Imports (DWCI) | |
| 2/18/2021 | 80MSHRESPIRATOR, SURGICAL | Division of West Coast Imports (DWCI) | |
| 1/22/2021 | 80MSHRESPIRATOR, SURGICAL | 479DV QUALITY | Division of West Coast Imports (DWCI) |
| 1/5/2021 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 1/5/2021 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/22/2020 | 80MSHRESPIRATOR, SURGICAL | Division of West Coast Imports (DWCI) | |
| 10/22/2020 | 80MSHRESPIRATOR, SURGICAL | Division of West Coast Imports (DWCI) | |
| 7/6/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GUANGDONG NAFEI INDUST HOLDING's FDA import refusal history?
GUANGDONG NAFEI INDUST HOLDING (FEI: 3016629652) has 12 FDA import refusal record(s) in our database, spanning from 7/6/2020 to 4/23/2021.
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 NAFEI INDUST HOLDING's FEI number is 3016629652.
What types of violations has GUANGDONG NAFEI INDUST HOLDING received?
GUANGDONG NAFEI INDUST HOLDING has been cited for 4 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 NAFEI INDUST HOLDING come from?
All FDA import refusal data for GUANGDONG NAFEI INDUST HOLDING 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.