Jeol Ltd.
✅ Low Risk
FEI: 3003303342 • Tachikawa, Tokyo • JAPAN
FEI Number
3003303342
Location
Tachikawa, Tokyo
Country
JAPANAddress
8-3 Shin-Suzuharu Bldg., Akebono-Cho, Tachikawa, Tokyo, Japan
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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 |
|---|---|---|---|
| 8/5/2010 | 75JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) FOR CLINICAL USE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/5/2010 | 75JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) FOR CLINICAL USE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/5/2010 | 75JJRELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/5/2010 | 75JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) FOR CLINICAL USE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Jeol Ltd.'s FDA import refusal history?
Jeol Ltd. (FEI: 3003303342) has 4 FDA import refusal record(s) in our database, spanning from 8/5/2010 to 8/5/2010.
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. Jeol Ltd.'s FEI number is 3003303342.
What types of violations has Jeol Ltd. received?
Jeol 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 Jeol Ltd. come from?
All FDA import refusal data for Jeol 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.