Kuraray Medical Kurashiki Plant
⚠️ Moderate Risk
FEI: 3004156195 • Kurashiki, Okayama • JAPAN
FEI Number
3004156195
Location
Kurashiki, Okayama
Country
JAPANAddress
( Kabu ) Kurare Kurashikijigyosho, 1621; Sakazu, Kurashiki, Okayama, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is Kuraray Medical Kurashiki Plant's FDA import refusal history?
Kuraray Medical Kurashiki Plant (FEI: 3004156195) has 1 FDA import refusal record(s) in our database, spanning from 6/15/2009 to 6/15/2009.
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. Kuraray Medical Kurashiki Plant's FEI number is 3004156195.
What types of violations has Kuraray Medical Kurashiki Plant received?
Kuraray Medical Kurashiki Plant has been cited for 3 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 Kuraray Medical Kurashiki Plant come from?
All FDA import refusal data for Kuraray Medical Kurashiki 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.