Kerview Sa
⚠️ Moderate Risk
FEI: 3007836205 • Montevidourugay • URUGUAY
FEI Number
3007836205
Location
Montevidourugay
Country
URUGUAYAddress
Ruta 8 Km 17500, Zonamerica, , Montevidourugay, , Uruguay
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).
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 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/7/2017 | 86HJXREADER, PRISM, OPHTHALMIC | Division of Southeast Imports (DSEI) | |
| 10/24/2014 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/24/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/25/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Kerview Sa's FDA import refusal history?
Kerview Sa (FEI: 3007836205) has 4 FDA import refusal record(s) in our database, spanning from 9/25/2014 to 4/7/2017.
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. Kerview Sa's FEI number is 3007836205.
What types of violations has Kerview Sa received?
Kerview Sa 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 Kerview Sa come from?
All FDA import refusal data for Kerview Sa 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.