Coastal Contacts
⚠️ Moderate Risk
FEI: 3007719624 • Vancouver, British Columbia • CANADA
FEI Number
3007719624
Location
Vancouver, British Columbia
Country
CANADAAddress
2955 Hebb Ave, , Vancouver, British Columbia, Canada
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 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/10/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Cincinnati District Office (CIN-DO) | |
| 2/10/2016 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | Cincinnati District Office (CIN-DO) |
| 1/22/2016 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | Cincinnati District Office (CIN-DO) |
| 1/21/2016 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | Cincinnati District Office (CIN-DO) |
| 1/20/2016 | 86HQZFRAME, SPECTACLE | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 1/20/2016 | 86HQZFRAME, SPECTACLE | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 12/30/2015 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | Cincinnati District Office (CIN-DO) |
| 4/21/2015 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | New Orleans District Office (NOL-DO) | |
| 3/4/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Coastal Contacts's FDA import refusal history?
Coastal Contacts (FEI: 3007719624) has 9 FDA import refusal record(s) in our database, spanning from 3/4/2013 to 2/10/2016.
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. Coastal Contacts's FEI number is 3007719624.
What types of violations has Coastal Contacts received?
Coastal Contacts has been cited for 3 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 Coastal Contacts come from?
All FDA import refusal data for Coastal Contacts 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.