Towa Chemical Industry Co., Ltd.
⚠️ Moderate Risk
FEI: 3000193077 • Tokyo • JAPAN
FEI Number
3000193077
Location
Tokyo
Country
JAPANAddress
8-7 Yaeau 2-Chome Chuo-Ku, , 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 |
|---|---|---|---|
| 6/24/2009 | 63XDZ83MANNITOL (DIAGNOSTIC AID) (DRUGS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/18/2009 | 63XDZ83MANNITOL (DIAGNOSTIC AID) (DRUGS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/21/2009 | 63XDZ83MANNITOL (DIAGNOSTIC AID) (DRUGS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 12/1/2008 | 63XDZ83MANNITOL (DIAGNOSTIC AID) (DRUGS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 12/1/2008 | 63XDZ83MANNITOL (DIAGNOSTIC AID) (DRUGS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Towa Chemical Industry Co., Ltd.'s FDA import refusal history?
Towa Chemical Industry Co., Ltd. (FEI: 3000193077) has 5 FDA import refusal record(s) in our database, spanning from 12/1/2008 to 6/24/2009.
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. Towa Chemical Industry Co., Ltd.'s FEI number is 3000193077.
What types of violations has Towa Chemical Industry Co., Ltd. received?
Towa Chemical Industry 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 Towa Chemical Industry Co., Ltd. come from?
All FDA import refusal data for Towa Chemical Industry 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.