Siegfried Evionnaz SA
⚠️ Moderate Risk
FEI: 3002807824 • Evionnaz, Valais • SWITZERLAND
FEI Number
3002807824
Location
Evionnaz, Valais
Country
SWITZERLANDAddress
route du Simplon 36, , Evionnaz, Valais, 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
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/29/2016 | 60QCS70TETRACAINE (ANESTHETIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 4/29/2016 | 60QCS70TETRACAINE (ANESTHETIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 5/15/2014 | 60QCS30BUPIVACAINE (ANESTHETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 3/5/2014 | 60QCS55BENOXINATE HCL (ANESTHETIC) | New York District Office (NYK-DO) | |
| 3/5/2014 | 60QCS55BENOXINATE HCL (ANESTHETIC) | New York District Office (NYK-DO) | |
| 3/5/2014 | 60QCS55BENOXINATE HCL (ANESTHETIC) | New York District Office (NYK-DO) | |
| 3/5/2014 | 60QCS79BUPIVACAINE HYDROCHLORIDE (ANESTHETIC) | New York District Office (NYK-DO) | |
| 3/5/2014 | 60QCS30BUPIVACAINE (ANESTHETIC) | New York District Office (NYK-DO) | |
| 8/14/2012 | 62UCS01BENZONATATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/6/2012 | 60QCS55BENOXINATE HCL (ANESTHETIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/22/2012 | 60QCS70TETRACAINE (ANESTHETIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/8/2012 | 60QCS34DIBUCAINE (ANESTHETIC) | New York District Office (NYK-DO) | |
| 4/5/2010 | 60QCS34DIBUCAINE (ANESTHETIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/2/2008 | 60QCS34DIBUCAINE (ANESTHETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 11/18/2008 | 60QCS70TETRACAINE (ANESTHETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Siegfried Evionnaz SA's FDA import refusal history?
Siegfried Evionnaz SA (FEI: 3002807824) has 15 FDA import refusal record(s) in our database, spanning from 11/18/2008 to 4/29/2016.
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. Siegfried Evionnaz SA's FEI number is 3002807824.
What types of violations has Siegfried Evionnaz SA received?
Siegfried Evionnaz 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 Siegfried Evionnaz SA come from?
All FDA import refusal data for Siegfried Evionnaz 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.