DONGGUAN LEIHUO MEDICAL DEVICE CO LTD
⚠️ Moderate Risk
FEI: 3016645706 • Dongguan, Guangdong • CHINA
FEI Number
3016645706
Location
Dongguan, Guangdong
Country
CHINAAddress
Dongshan Yongshenglu No. Room 47, 101 Qishi; Dongshan Yongsheglu No, Dongguan, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
STD LABEL
The article appears to not bear labeling prescribed by the performance standard established under section 514.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/11/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | Division of Southeast Imports (DSEI) | |
| 11/5/2020 | 80MSHRESPIRATOR, SURGICAL | Division of Southeast Imports (DSEI) | |
| 9/22/2020 | 80ORWN95 RESPIRATOR WITH ANTIMICROBIAL/ANTIVIRAL AGENT FOR USE BY THE GENERAL PUBLIC IN PUBLIC HEALTH MED | Division of Southeast Imports (DSEI) | |
| 9/11/2020 | 80MSHRESPIRATOR, SURGICAL | Division of Southeast Imports (DSEI) | |
| 8/22/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 8/17/2020 | 80QKUNON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS (FFRS) | Division of Southeast Imports (DSEI) | |
| 7/14/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 7/13/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 7/8/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 7/6/2020 | 80MSHRESPIRATOR, SURGICAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DONGGUAN LEIHUO MEDICAL DEVICE CO LTD's FDA import refusal history?
DONGGUAN LEIHUO MEDICAL DEVICE CO LTD (FEI: 3016645706) has 10 FDA import refusal record(s) in our database, spanning from 7/6/2020 to 12/11/2020.
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 LEIHUO MEDICAL DEVICE CO LTD's FEI number is 3016645706.
What types of violations has DONGGUAN LEIHUO MEDICAL DEVICE CO LTD received?
DONGGUAN LEIHUO MEDICAL DEVICE CO LTD has been cited for 8 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 LEIHUO MEDICAL DEVICE CO LTD come from?
All FDA import refusal data for DONGGUAN LEIHUO MEDICAL DEVICE 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.