Dupont-Asahi Flash Spun Products Co
⚠️ Moderate Risk
FEI: 3007335835 • Chiyoda, Tokyo • JAPAN
FEI Number
3007335835
Location
Chiyoda, Tokyo
Country
JAPANAddress
2 Chome 11-1, Nagata-Cho, Chiyoda, 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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/18/2009 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | Los Angeles District Office (LOS-DO) | |
| 3/18/2009 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | Los Angeles District Office (LOS-DO) | |
| 3/13/2009 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | Los Angeles District Office (LOS-DO) | |
| 3/13/2009 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Dupont-Asahi Flash Spun Products Co's FDA import refusal history?
Dupont-Asahi Flash Spun Products Co (FEI: 3007335835) has 4 FDA import refusal record(s) in our database, spanning from 3/13/2009 to 3/18/2009.
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. Dupont-Asahi Flash Spun Products Co's FEI number is 3007335835.
What types of violations has Dupont-Asahi Flash Spun Products Co received?
Dupont-Asahi Flash Spun Products Co has been cited for 2 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 Dupont-Asahi Flash Spun Products Co come from?
All FDA import refusal data for Dupont-Asahi Flash Spun Products Co 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.