Ena Optical Manufacturing Co.
⚠️ Moderate Risk
FEI: 3005737816 • Nakatsugawa, Gifu • JAPAN
FEI Number
3005737816
Location
Nakatsugawa, Gifu
Country
JAPANAddress
48, Naegi, Nakatsugawa, Gifu, 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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/4/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/11/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/8/2011 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ena Optical Manufacturing Co.'s FDA import refusal history?
Ena Optical Manufacturing Co. (FEI: 3005737816) has 3 FDA import refusal record(s) in our database, spanning from 8/8/2011 to 3/4/2013.
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. Ena Optical Manufacturing Co.'s FEI number is 3005737816.
What types of violations has Ena Optical Manufacturing Co. received?
Ena Optical Manufacturing 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 Ena Optical Manufacturing Co. come from?
All FDA import refusal data for Ena Optical Manufacturing 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.