ImportRefusal LogoImportRefusal

Kythera International B.V.

⚠️ Moderate Risk

FEI: 3005762100 • Eindhoven, Noord-Brabant • NETHERLANDS

FEI

FEI Number

3005762100

📍

Location

Eindhoven, Noord-Brabant

🇳🇱
🏢

Address

Ondernemingenweg 6, , Eindhoven, Noord-Brabant, Netherlands

Moderate Risk

FDA Import Risk Assessment

33.6
LowModerateHighCritical

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

Statistics

10
Total Refusals
1
Unique Violations
11/14/2006
Latest Refusal
11/14/2006
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

34110×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
11/14/2006
80KMJLUBRICANT, PATIENT
341REGISTERED
Los Angeles District Office (LOS-DO)
11/14/2006
80KMJLUBRICANT, PATIENT
341REGISTERED
Los Angeles District Office (LOS-DO)
11/14/2006
80KMJLUBRICANT, PATIENT
341REGISTERED
Los Angeles District Office (LOS-DO)
11/14/2006
80KMJLUBRICANT, PATIENT
341REGISTERED
Los Angeles District Office (LOS-DO)
11/14/2006
80KMJLUBRICANT, PATIENT
341REGISTERED
Los Angeles District Office (LOS-DO)
11/14/2006
80KMJLUBRICANT, PATIENT
341REGISTERED
Los Angeles District Office (LOS-DO)
11/14/2006
80KMJLUBRICANT, PATIENT
341REGISTERED
Los Angeles District Office (LOS-DO)
11/14/2006
80KMJLUBRICANT, PATIENT
341REGISTERED
Los Angeles District Office (LOS-DO)
11/14/2006
80KMJLUBRICANT, PATIENT
341REGISTERED
Los Angeles District Office (LOS-DO)
11/14/2006
80KMJLUBRICANT, PATIENT
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Kythera International B.V.'s FDA import refusal history?

Kythera International B.V. (FEI: 3005762100) has 10 FDA import refusal record(s) in our database, spanning from 11/14/2006 to 11/14/2006.

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. Kythera International B.V.'s FEI number is 3005762100.

What types of violations has Kythera International B.V. received?

Kythera International B.V. 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 Kythera International B.V. come from?

All FDA import refusal data for Kythera International B.V. 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.