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Kaysersberg Pharmaceuticals SAS

⚠️ Moderate Risk

FEI: 3002806288 • Kaysersberg, Haut Rhin • FRANCE

FEI

FEI Number

3002806288

📍

Location

Kaysersberg, Haut Rhin

🇫🇷

Country

FRANCE
🏢

Address

23 avenue Georges Ferrenbach, , Kaysersberg, Haut Rhin, France

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
11/9/2020
Latest Refusal
11/9/2020
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

38741×

708NEWDRUG

The article has been determined to be a new drug without an approved new drug application.

Refusal History

DateProductViolationsDivision
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.