WISE MEDICAL PRODUCTS CO LTD
⚠️ High Risk
FEI: 3024729429 • Jiujiang, Jiangxi • CHINA
FEI Number
3024729429
Location
Jiujiang, Jiangxi
Country
CHINAAddress
North Of Shenhua Port, Hukou County, , Jiujiang, Jiangxi, 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/21/2024 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northern Border Imports (DNBI) |
| 5/21/2024 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northern Border Imports (DNBI) |
| 5/21/2024 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northern Border Imports (DNBI) |
| 5/21/2024 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northern Border Imports (DNBI) |
| 2/1/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northern Border Imports (DNBI) |
| 2/1/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northern Border Imports (DNBI) |
| 2/1/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northern Border Imports (DNBI) |
| 2/1/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northern Border Imports (DNBI) |
| 2/1/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is WISE MEDICAL PRODUCTS CO LTD's FDA import refusal history?
WISE MEDICAL PRODUCTS CO LTD (FEI: 3024729429) has 9 FDA import refusal record(s) in our database, spanning from 2/1/2024 to 5/21/2024.
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. WISE MEDICAL PRODUCTS CO LTD's FEI number is 3024729429.
What types of violations has WISE MEDICAL PRODUCTS CO LTD received?
WISE MEDICAL PRODUCTS CO LTD has been cited for 1 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 WISE MEDICAL PRODUCTS CO LTD come from?
All FDA import refusal data for WISE MEDICAL PRODUCTS 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.