ImportRefusal LogoImportRefusal

Kahn

⚠️ Moderate Risk

FEI: 3003583335 • Givrins • SWITZERLAND

FEI

FEI Number

3003583335

📍

Location

Givrins

🇨🇭
🏢

Address

Ch De Sodome, , Givrins, , Switzerland

Moderate Risk

FDA Import Risk Assessment

32.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
3/14/2002
Latest Refusal
3/14/2002
Earliest Refusal

Score Breakdown

Violation Severity
57.5×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
3/14/2002
54AYY99VITAMIN, N.E.C.
473LABELING
New Orleans District Office (NOL-DO)
3/14/2002
54AYY99VITAMIN, N.E.C.
473LABELING
New Orleans District Office (NOL-DO)
3/14/2002
74JOQGENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE
126FAILS STD
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Kahn's FDA import refusal history?

Kahn (FEI: 3003583335) has 3 FDA import refusal record(s) in our database, spanning from 3/14/2002 to 3/14/2002.

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. Kahn's FEI number is 3003583335.

What types of violations has Kahn received?

Kahn 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 Kahn come from?

All FDA import refusal data for Kahn 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.