Viarden Sa
⚠️ Moderate Risk
FEI: 3004127368 • Cuauhtemoc • MEXICO
FEI Number
3004127368
Location
Cuauhtemoc
Country
MEXICOAddress
Marcelino Davalos No 24, , Cuauhtemoc, , Mexico
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/28/2005 | 76DZADRILL, DENTAL, INTRAORAL | Division of Southeast Imports (DSEI) | |
| 1/28/2005 | 76MZWDENTAL CEMENT WITHOUT ZINC-OXIDE EUGENOL AS AN ULCER COVERING FOR PAIN RELIEF | Division of Southeast Imports (DSEI) | |
| 1/28/2005 | 76JESFLOSS, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Viarden Sa's FDA import refusal history?
Viarden Sa (FEI: 3004127368) has 3 FDA import refusal record(s) in our database, spanning from 1/28/2005 to 1/28/2005.
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. Viarden Sa's FEI number is 3004127368.
What types of violations has Viarden Sa received?
Viarden Sa has been cited for 2 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 Viarden Sa come from?
All FDA import refusal data for Viarden 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.