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Pk Benelux Bv

⚠️ Moderate Risk

FEI: 3003508413 • Uden, Noord-Brabant • NETHERLANDS

FEI

FEI Number

3003508413

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Location

Uden, Noord-Brabant

🇳🇱
🏢

Address

Vluchtoord 17, , Uden, Noord-Brabant, Netherlands

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
8/9/2010
Latest Refusal
8/9/2010
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
8/9/2010
63XCY99DIAGOSTIC AID (DRUGS) N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Pk Benelux Bv's FDA import refusal history?

Pk Benelux Bv (FEI: 3003508413) has 1 FDA import refusal record(s) in our database, spanning from 8/9/2010 to 8/9/2010.

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. Pk Benelux Bv's FEI number is 3003508413.

What types of violations has Pk Benelux Bv received?

Pk Benelux Bv 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 Pk Benelux Bv come from?

All FDA import refusal data for Pk Benelux Bv 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.