MIKUNI KOGYO CO LTD. KOHAN PLANT
✅ Low Risk
FEI: 3008069922 • Okaya, Nagano • JAPAN
FEI Number
3008069922
Location
Okaya, Nagano
Country
JAPANAddress
3 Chome 2-23, Kohan, Okaya, Nagano, 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
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 |
|---|---|---|---|
| 8/28/2014 | 76DZMNEEDLE, DENTAL | 118NOT LISTED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is MIKUNI KOGYO CO LTD. KOHAN PLANT's FDA import refusal history?
MIKUNI KOGYO CO LTD. KOHAN PLANT (FEI: 3008069922) has 1 FDA import refusal record(s) in our database, spanning from 8/28/2014 to 8/28/2014.
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. MIKUNI KOGYO CO LTD. KOHAN PLANT's FEI number is 3008069922.
What types of violations has MIKUNI KOGYO CO LTD. KOHAN PLANT received?
MIKUNI KOGYO CO LTD. KOHAN PLANT 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 MIKUNI KOGYO CO LTD. KOHAN PLANT come from?
All FDA import refusal data for MIKUNI KOGYO CO LTD. KOHAN PLANT 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.