DONGGUAN XIANDA MEDICAL EQUIPMENT CO LTD
⚠️ High Risk
FEI: 3016644982 • Dong Guan, Guangdong • CHINA
FEI Number
3016644982
Location
Dong Guan, Guangdong
Country
CHINAAddress
Building 7 Room 301, No. 40 Longyan Road; Longyanguanli Humenzhen, Dong Guan, Guangdong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 |
|---|---|---|---|
| 10/29/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southwest Imports (DSWI) | |
| 10/29/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southwest Imports (DSWI) | |
| 10/29/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southwest Imports (DSWI) | |
| 10/1/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Northeast Imports (DNEI) |
| 10/1/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Northeast Imports (DNEI) |
| 8/26/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/17/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 6/16/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/16/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of West Coast Imports (DWCI) |
| 6/12/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 5/18/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of West Coast Imports (DWCI) |
| 5/18/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of West Coast Imports (DWCI) |
| 5/18/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is DONGGUAN XIANDA MEDICAL EQUIPMENT CO LTD's FDA import refusal history?
DONGGUAN XIANDA MEDICAL EQUIPMENT CO LTD (FEI: 3016644982) has 14 FDA import refusal record(s) in our database, spanning from 5/18/2020 to 10/29/2020.
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. DONGGUAN XIANDA MEDICAL EQUIPMENT CO LTD's FEI number is 3016644982.
What types of violations has DONGGUAN XIANDA MEDICAL EQUIPMENT CO LTD received?
DONGGUAN XIANDA MEDICAL EQUIPMENT 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 DONGGUAN XIANDA MEDICAL EQUIPMENT CO LTD come from?
All FDA import refusal data for DONGGUAN XIANDA MEDICAL EQUIPMENT 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.