Santec Corporation
⚠️ Moderate Risk
FEI: 3003582065 • Komaki, Aichi • JAPAN
FEI Number
3003582065
Location
Komaki, Aichi
Country
JAPANAddress
5823 35, Ohkusa-Nenjyozaka, Komaki, Aichi, 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 REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/2/2011 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | New Orleans District Office (NOL-DO) |
| 3/29/2005 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 126FAILS STD | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Santec Corporation's FDA import refusal history?
Santec Corporation (FEI: 3003582065) has 3 FDA import refusal record(s) in our database, spanning from 3/29/2005 to 11/2/2011.
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. Santec Corporation's FEI number is 3003582065.
What types of violations has Santec Corporation received?
Santec Corporation 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 Santec Corporation come from?
All FDA import refusal data for Santec 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.