GUANGZHOU SUNJOY AUTO SUPPLIES CO., LTD.
⚠️ Moderate Risk
FEI: 3016615986 • Gaungdong, Guangdong • CHINA
FEI Number
3016615986
Location
Gaungdong, Guangdong
Country
CHINAAddress
Xixian Industrial Zone,Kengtou, Nancun Town, Panyu District, Gaunzhou, Gaungdong, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/31/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 8/31/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 8/10/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | Division of Southeast Imports (DSEI) | |
| 7/14/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 7/14/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 7/13/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 7/2/2020 | 80NZJRESPIRATOR, N95, HOME USE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GUANGZHOU SUNJOY AUTO SUPPLIES CO., LTD.'s FDA import refusal history?
GUANGZHOU SUNJOY AUTO SUPPLIES CO., LTD. (FEI: 3016615986) has 8 FDA import refusal record(s) in our database, spanning from 6/19/2020 to 8/31/2020.
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. GUANGZHOU SUNJOY AUTO SUPPLIES CO., LTD.'s FEI number is 3016615986.
What types of violations has GUANGZHOU SUNJOY AUTO SUPPLIES CO., LTD. received?
GUANGZHOU SUNJOY AUTO SUPPLIES 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 SUNJOY AUTO SUPPLIES CO., LTD. come from?
All FDA import refusal data for GUANGZHOU SUNJOY AUTO SUPPLIES 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.