Geistlich Pharma, Geitlich Soehne Ag
⚠️ Moderate Risk
FEI: 3002807102 • Wolhusen, Luzern • SWITZERLAND
FEI Number
3002807102
Location
Wolhusen, Luzern
Country
SWITZERLANDAddress
Bahnhofstrasse 40, , Wolhusen, Luzern, 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 |
|---|---|---|---|
| 2/1/2012 | 76NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | 118NOT LISTED | New York District Office (NYK-DO) |
| 2/1/2012 | 76EMKCURETTE, SURGICAL, DENTAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 2/1/2012 | 76NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | 118NOT LISTED | New York District Office (NYK-DO) |
| 2/1/2012 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | New York District Office (NYK-DO) |
| 2/1/2012 | 76NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | 118NOT LISTED | New York District Office (NYK-DO) |
| 2/1/2012 | 76EIRSCISSORS, COLLAR AND CROWN | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Geistlich Pharma, Geitlich Soehne Ag's FDA import refusal history?
Geistlich Pharma, Geitlich Soehne Ag (FEI: 3002807102) has 6 FDA import refusal record(s) in our database, spanning from 2/1/2012 to 2/1/2012.
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. Geistlich Pharma, Geitlich Soehne Ag's FEI number is 3002807102.
What types of violations has Geistlich Pharma, Geitlich Soehne Ag received?
Geistlich Pharma, Geitlich Soehne Ag 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 Geistlich Pharma, Geitlich Soehne Ag come from?
All FDA import refusal data for Geistlich Pharma, Geitlich Soehne Ag 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.