JIANGSU KANGJIE MEDICAL DEVICES Co Ltd
⚠️ Moderate Risk
FEI: 3016851874 • Taizhou, Jiangsu • CHINA
FEI Number
3016851874
Location
Taizhou, Jiangsu
Country
CHINAAddress
No. 6 Zhanbei Road, , Taizhou, Jiangsu, 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
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.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 12/7/2021 | 80KXGAPPLICATOR, ABSORBENT TIPPED, STERILE | Division of West Coast Imports (DWCI) | |
| 9/12/2021 | 80KXGAPPLICATOR, ABSORBENT TIPPED, STERILE | Division of Southeast Imports (DSEI) | |
| 5/28/2021 | 80KXGAPPLICATOR, ABSORBENT TIPPED, STERILE | 333LACKS FIRM | Division of West Coast Imports (DWCI) |
| 5/28/2021 | 80KXGAPPLICATOR, ABSORBENT TIPPED, STERILE | 333LACKS FIRM | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is JIANGSU KANGJIE MEDICAL DEVICES Co Ltd's FDA import refusal history?
JIANGSU KANGJIE MEDICAL DEVICES Co Ltd (FEI: 3016851874) has 4 FDA import refusal record(s) in our database, spanning from 5/28/2021 to 12/7/2021.
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. JIANGSU KANGJIE MEDICAL DEVICES Co Ltd's FEI number is 3016851874.
What types of violations has JIANGSU KANGJIE MEDICAL DEVICES Co Ltd received?
JIANGSU KANGJIE MEDICAL DEVICES Co Ltd 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 JIANGSU KANGJIE MEDICAL DEVICES Co Ltd come from?
All FDA import refusal data for JIANGSU KANGJIE MEDICAL DEVICES 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.