Contour Optik Inc.
⚠️ Moderate Risk
FEI: 3002340647 • Chiayl • TAIWAN
FEI Number
3002340647
Location
Chiayl
Country
TAIWANAddress
6 Industrial Fifth Roadtou Chiau, , Chiayl, , Taiwan
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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).
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/26/2010 | 86HOISPECTACLE, MAGNIFYING | 235NOT IMPACT | San Francisco District Office (SAN-DO) |
| 2/17/2010 | 86HOISPECTACLE, MAGNIFYING | San Francisco District Office (SAN-DO) | |
| 9/8/2009 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | San Francisco District Office (SAN-DO) |
| 8/26/2009 | 86HQZFRAME, SPECTACLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/9/2008 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/9/2008 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 5/20/2008 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Contour Optik Inc.'s FDA import refusal history?
Contour Optik Inc. (FEI: 3002340647) has 7 FDA import refusal record(s) in our database, spanning from 5/20/2008 to 5/26/2010.
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. Contour Optik Inc.'s FEI number is 3002340647.
What types of violations has Contour Optik Inc. received?
Contour Optik Inc. has been cited for 4 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 Contour Optik Inc. come from?
All FDA import refusal data for Contour Optik 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.