IMPROVE MEDICAL (HUNAN) CO., LTD.
⚠️ Moderate Risk
FEI: 3016717403 • Chenzhou, Hunan • CHINA
FEI Number
3016717403
Location
Chenzhou, Hunan
Country
CHINAAddress
No. 6 Yizhang East Avenue, Economic Development, District, 424200 Yizhang, Chenzhou, Hunan, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/28/2021 | 80NZJRESPIRATOR, N95, HOME USE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/28/2021 | 80NZJRESPIRATOR, N95, HOME USE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/28/2021 | 80NZJRESPIRATOR, N95, HOME USE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/28/2021 | 80NZJRESPIRATOR, N95, HOME USE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/16/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is IMPROVE MEDICAL (HUNAN) CO., LTD.'s FDA import refusal history?
IMPROVE MEDICAL (HUNAN) CO., LTD. (FEI: 3016717403) has 5 FDA import refusal record(s) in our database, spanning from 9/16/2020 to 1/28/2021.
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. IMPROVE MEDICAL (HUNAN) CO., LTD.'s FEI number is 3016717403.
What types of violations has IMPROVE MEDICAL (HUNAN) CO., LTD. received?
IMPROVE MEDICAL (HUNAN) 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 IMPROVE MEDICAL (HUNAN) CO., LTD. come from?
All FDA import refusal data for IMPROVE MEDICAL (HUNAN) 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.