FUJITA MEDICAL INSTRUMENTS CO., LTD
⚠️ Moderate Risk
FEI: 3001595398 • Bunkyo, Tokyo • JAPAN
FEI Number
3001595398
Location
Bunkyo, Tokyo
Country
JAPANAddress
3-6-1 Bunkyo-Ku, Hongo, Bunkyo, Tokyo, Japan
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/5/2011 | 84GZXINSTRUMENT, MICROSURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/25/2011 | 80GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/14/2004 | 79GDOAPPLIER, SURGICAL, CLIP | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is FUJITA MEDICAL INSTRUMENTS CO., LTD's FDA import refusal history?
FUJITA MEDICAL INSTRUMENTS CO., LTD (FEI: 3001595398) has 3 FDA import refusal record(s) in our database, spanning from 8/14/2004 to 12/5/2011.
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. FUJITA MEDICAL INSTRUMENTS CO., LTD's FEI number is 3001595398.
What types of violations has FUJITA MEDICAL INSTRUMENTS CO., LTD received?
FUJITA MEDICAL INSTRUMENTS 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 FUJITA MEDICAL INSTRUMENTS CO., LTD come from?
All FDA import refusal data for FUJITA MEDICAL INSTRUMENTS 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.