Innova Vision Inc.
⚠️ Moderate Risk
FEI: 3003746024 • Hsin-Chu • TAIWAN
FEI Number
3003746024
Location
Hsin-Chu
Country
TAIWANAddress
Chiung-Lin Village, No. 231-1 Wen-Te Road, Hsin-Chu, , 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).
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).
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.
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/16/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 9/8/2004 | 86HPXLENS, CONTACT (POLYMETHYLMETHACRYLATE) | Seattle District Office (SEA-DO) | |
| 9/10/2003 | 86MVNLENS, CONTACT (DISPOSABLE) | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Innova Vision Inc.'s FDA import refusal history?
Innova Vision Inc. (FEI: 3003746024) has 3 FDA import refusal record(s) in our database, spanning from 9/10/2003 to 5/16/2013.
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. Innova Vision Inc.'s FEI number is 3003746024.
What types of violations has Innova Vision Inc. received?
Innova Vision Inc. has been cited for 5 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 Innova Vision Inc. come from?
All FDA import refusal data for Innova Vision 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.