Sky Optical Llc
⚠️ High Risk
FEI: 3011845112 • Dubai • UNITED ARAB EMIRATES
FEI Number
3011845112
Location
Dubai
Country
UNITED ARAB EMIRATESAddress
Gold And Diamond P, , Dubai, , United Arab Emirates
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/5/2024 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/5/2024 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/5/2024 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/5/2024 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/5/2024 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/5/2024 | 86HOISPECTACLE, MAGNIFYING | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/5/2024 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/5/2024 | 86HOISPECTACLE, MAGNIFYING | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/25/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/25/2023 | 86NICLENS, CONTACT, FOR READING DISCOMFORT | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/14/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/14/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/14/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/14/2023 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/14/2023 | 86HQLLENS, INTRAOCULAR | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/14/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/14/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/14/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 3/13/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 3/13/2023 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 3/10/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 3/10/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 2/17/2023 | 86HOISPECTACLE, MAGNIFYING | Division of Southeast Imports (DSEI) | |
| 2/16/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 2/16/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 2/16/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Sky Optical Llc's FDA import refusal history?
Sky Optical Llc (FEI: 3011845112) has 26 FDA import refusal record(s) in our database, spanning from 2/16/2023 to 4/5/2024.
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. Sky Optical Llc's FEI number is 3011845112.
What types of violations has Sky Optical Llc received?
Sky Optical Llc 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 Sky Optical Llc come from?
All FDA import refusal data for Sky Optical Llc 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.