Tongruhn Medical Products Co.,Ltd.
⚠️ Moderate Risk
FEI: 3004117953 • Dandong, Liaoning • CHINA
FEI Number
3004117953
Location
Dandong, Liaoning
Country
CHINAAddress
88 Tongxing, Zhenan, Dandong, Liaoning, 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 |
|---|---|---|---|
| 8/3/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 5/17/2005 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 3/25/2005 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Tongruhn Medical Products Co.,Ltd.'s FDA import refusal history?
Tongruhn Medical Products Co.,Ltd. (FEI: 3004117953) has 3 FDA import refusal record(s) in our database, spanning from 3/25/2005 to 8/3/2006.
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. Tongruhn Medical Products Co.,Ltd.'s FEI number is 3004117953.
What types of violations has Tongruhn Medical Products Co.,Ltd. received?
Tongruhn 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 Tongruhn Medical Products Co.,Ltd. come from?
All FDA import refusal data for Tongruhn 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.