Manufactures Doutils Dumont Sa
⚠️ Moderate Risk
FEI: 3001115212 • Montignez • SWITZERLAND
FEI Number
3001115212
Location
Montignez
Country
SWITZERLANDAddress
Ch 2924, , Montignez, , Switzerland
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/29/2024 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Manufactures Doutils Dumont Sa's FDA import refusal history?
Manufactures Doutils Dumont Sa (FEI: 3001115212) has 1 FDA import refusal record(s) in our database, spanning from 7/29/2024 to 7/29/2024.
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. Manufactures Doutils Dumont Sa's FEI number is 3001115212.
What types of violations has Manufactures Doutils Dumont Sa received?
Manufactures Doutils Dumont Sa has been cited for 1 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 Manufactures Doutils Dumont Sa come from?
All FDA import refusal data for Manufactures Doutils Dumont 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.