I-see Vision Technology Inc
⚠️ Moderate Risk
FEI: 3008111539 • Hsinchu • TAIWAN
FEI Number
3008111539
Location
Hsinchu
Country
TAIWANAddress
1 F, No. 45 Lane; 2 Section 2, Kuang-Fu, Hsinchu, , 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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).
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/18/2021 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 11/8/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 2/26/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 8/17/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 473LABELING | Division of Southeast Imports (DSEI) |
| 1/11/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 8/4/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 2/19/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) | |
| 2/19/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) | |
| 2/19/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) | |
| 2/19/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) | |
| 2/19/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) | |
| 2/19/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) | |
| 2/19/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is I-see Vision Technology Inc's FDA import refusal history?
I-see Vision Technology Inc (FEI: 3008111539) has 13 FDA import refusal record(s) in our database, spanning from 2/19/2014 to 5/18/2021.
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. I-see Vision Technology Inc's FEI number is 3008111539.
What types of violations has I-see Vision Technology Inc received?
I-see Vision Technology Inc has been cited for 7 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 I-see Vision Technology Inc come from?
All FDA import refusal data for I-see Vision Technology 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.