Salzmann Ag, Salzmann Medico
⚠️ Moderate Risk
FEI: 3003457372 • St. Gallen, St. Gallen • SWITZERLAND
FEI Number
3003457372
Location
St. Gallen, St. Gallen
Country
SWITZERLANDAddress
Rorschacher Strasse 304, , St. Gallen, St. Gallen, 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
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 |
|---|---|---|---|
| 1/5/2016 | 79GAISTRIPPER, VEIN, REUSABLE | 118NOT LISTED | Detroit District Office (DET-DO) |
| 1/5/2016 | 79GAISTRIPPER, VEIN, REUSABLE | 118NOT LISTED | Detroit District Office (DET-DO) |
| 1/5/2016 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Detroit District Office (DET-DO) |
| 1/5/2016 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Detroit District Office (DET-DO) |
| 1/5/2016 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Detroit District Office (DET-DO) |
| 7/31/2012 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/31/2012 | 79GAISTRIPPER, VEIN, REUSABLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Salzmann Ag, Salzmann Medico's FDA import refusal history?
Salzmann Ag, Salzmann Medico (FEI: 3003457372) has 7 FDA import refusal record(s) in our database, spanning from 7/31/2012 to 1/5/2016.
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. Salzmann Ag, Salzmann Medico's FEI number is 3003457372.
What types of violations has Salzmann Ag, Salzmann Medico received?
Salzmann Ag, Salzmann Medico 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 Salzmann Ag, Salzmann Medico come from?
All FDA import refusal data for Salzmann Ag, Salzmann Medico 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.