Kaysersberg Pharmaceuticals SAS
⚠️ Moderate Risk
FEI: 3002806288 • Kaysersberg, Haut Rhin • FRANCE
FEI Number
3002806288
Location
Kaysersberg, Haut Rhin
Country
FRANCEAddress
23 avenue Georges Ferrenbach, , Kaysersberg, Haut Rhin, France
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
708NEWDRUG
The article has been determined to be a new drug without an approved new drug application.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/9/2020 | 65LDK16HYDROXYPROPYL CELLULOSE (PROTECTANT) | 3874708NEWDRUG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Kaysersberg Pharmaceuticals SAS's FDA import refusal history?
Kaysersberg Pharmaceuticals SAS (FEI: 3002806288) has 1 FDA import refusal record(s) in our database, spanning from 11/9/2020 to 11/9/2020.
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. Kaysersberg Pharmaceuticals SAS's FEI number is 3002806288.
What types of violations has Kaysersberg Pharmaceuticals SAS received?
Kaysersberg Pharmaceuticals SAS 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 Kaysersberg Pharmaceuticals SAS come from?
All FDA import refusal data for Kaysersberg Pharmaceuticals SAS 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.