Seiko Contaclens Inc
⚠️ Moderate Risk
FEI: 3002776786 • Taito, Tokyo • JAPAN
FEI Number
3002776786
Location
Taito, Tokyo
Country
JAPANAddress
4-Chome Shibusawa Bldg 28-11, Taito, Taito, 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
Frequently Asked Questions
What is Seiko Contaclens Inc's FDA import refusal history?
Seiko Contaclens Inc (FEI: 3002776786) has 2 FDA import refusal record(s) in our database, spanning from 12/30/2003 to 1/27/2004.
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. Seiko Contaclens Inc's FEI number is 3002776786.
What types of violations has Seiko Contaclens Inc received?
Seiko Contaclens Inc 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 Seiko Contaclens Inc come from?
All FDA import refusal data for Seiko Contaclens Inc 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.