QUANTUM CO., LTD.
⚠️ Moderate Risk
FEI: 3007583547 • Zibo, Shandong • CHINA
FEI Number
3007583547
Location
Zibo, Shandong
Country
CHINAAddress
Qilu Chemical Industrial Park Lot 3, No 21 Liqingnanlu; Linzi District, Zibo, 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 |
|---|---|---|---|
| 3/21/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New Orleans District Office (NOL-DO) |
| 3/21/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New Orleans District Office (NOL-DO) |
| 3/21/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New Orleans District Office (NOL-DO) |
| 3/21/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New Orleans District Office (NOL-DO) |
| 1/30/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New York District Office (NYK-DO) |
| 1/30/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New York District Office (NYK-DO) |
| 1/30/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New York District Office (NYK-DO) |
| 12/11/2009 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is QUANTUM CO., LTD.'s FDA import refusal history?
QUANTUM CO., LTD. (FEI: 3007583547) has 8 FDA import refusal record(s) in our database, spanning from 12/11/2009 to 3/21/2014.
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. QUANTUM CO., LTD.'s FEI number is 3007583547.
What types of violations has QUANTUM CO., LTD. received?
QUANTUM 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 QUANTUM CO., LTD. come from?
All FDA import refusal data for QUANTUM 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.