Shandong Zhiyuan Medical Products Co Ltd
⚠️ Moderate Risk
FEI: 3009741833 • Qingzhou, Shandong • CHINA
FEI Number
3009741833
Location
Qingzhou, Shandong
Country
CHINAAddress
Mihe Industry Park, NO. 20 Shengshui Road, Qingzhou, Shandong, 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
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 |
|---|---|---|---|
| 10/6/2023 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northern Border Imports (DNBI) |
| 10/6/2023 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northern Border Imports (DNBI) |
| 10/6/2023 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Shandong Zhiyuan Medical Products Co Ltd's FDA import refusal history?
Shandong Zhiyuan Medical Products Co Ltd (FEI: 3009741833) has 3 FDA import refusal record(s) in our database, spanning from 10/6/2023 to 10/6/2023.
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. Shandong Zhiyuan Medical Products Co Ltd's FEI number is 3009741833.
What types of violations has Shandong Zhiyuan Medical Products Co Ltd received?
Shandong Zhiyuan 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 Shandong Zhiyuan Medical Products Co Ltd come from?
All FDA import refusal data for Shandong Zhiyuan 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.