SHIBUYA CORPORATION
⚠️ Moderate Risk
FEI: 3016250252 • Kanazawa, Ishikawa • JAPAN
FEI Number
3016250252
Location
Kanazawa, Ishikawa
Country
JAPANAddress
2 Chome 72, Wakamiya, Kanazawa, Ishikawa, 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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/26/2024 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | 237NO PMA | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHIBUYA CORPORATION's FDA import refusal history?
SHIBUYA CORPORATION (FEI: 3016250252) has 1 FDA import refusal record(s) in our database, spanning from 1/26/2024 to 1/26/2024.
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. SHIBUYA CORPORATION's FEI number is 3016250252.
What types of violations has SHIBUYA CORPORATION received?
SHIBUYA CORPORATION 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 SHIBUYA CORPORATION come from?
All FDA import refusal data for SHIBUYA CORPORATION 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.