Coastal Contacts Inc.
⚠️ Moderate Risk
FEI: 3006066935 • Vancouver, British Columbia • CANADA
FEI Number
3006066935
Location
Vancouver, British Columbia
Country
CANADAAddress
2985 Virtual Way, Suite 320, , 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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/4/2017 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 3/17/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 3/17/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 3/17/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 3/17/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 3/17/2017 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 3/17/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 8/27/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/27/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/27/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/27/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/27/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/27/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/1/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Coastal Contacts Inc.'s FDA import refusal history?
Coastal Contacts Inc. (FEI: 3006066935) has 27 FDA import refusal record(s) in our database, spanning from 3/1/2013 to 4/4/2017.
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 Inc.'s FEI number is 3006066935.
What types of violations has Coastal Contacts Inc. received?
Coastal Contacts Inc. has been cited for 6 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 Inc. come from?
All FDA import refusal data for Coastal Contacts 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.