TOSOH CORPORATION
⚠️ High Risk
FEI: 3013314450 • Minato, Tokyo • JAPAN
FEI Number
3013314450
Location
Minato, Tokyo
Country
JAPANAddress
Higashiso ( Kabu 3 Chome 8-2 Shibakoen First Bldg., , Minato, Tokyo, Japan
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/15/2023 | 81JPDHEMOGLOBIN A2 QUANTITATION | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 3/15/2023 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 3/15/2023 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 3/15/2023 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 3/15/2023 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 3/15/2023 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 3/15/2023 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is TOSOH CORPORATION's FDA import refusal history?
TOSOH CORPORATION (FEI: 3013314450) has 7 FDA import refusal record(s) in our database, spanning from 3/15/2023 to 3/15/2023.
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. TOSOH CORPORATION's FEI number is 3013314450.
What types of violations has TOSOH CORPORATION received?
TOSOH 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 TOSOH CORPORATION come from?
All FDA import refusal data for TOSOH 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.