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Crucell Holland Bv

⚠️ High Risk

FEI: 3004491997 • Leiden, Zuid-Holland • NETHERLANDS

FEI

FEI Number

3004491997

📍

Location

Leiden, Zuid-Holland

🇳🇱
🏢

Address

Archimedesweg 4, , Leiden, Zuid-Holland, Netherlands

High Risk

FDA Import Risk Assessment

51.4
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

6
Total Refusals
1
Unique Violations
12/18/2015
Latest Refusal
12/18/2015
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

716×

NO LICENSE

The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use

Refusal History

DateProductViolationsDivision
12/18/2015
57CL99VIRAL VACCINES, N.E.C.
71NO LICENSE
Division of Northeast Imports (DNEI)
12/18/2015
57CL99VIRAL VACCINES, N.E.C.
71NO LICENSE
Division of Northeast Imports (DNEI)
12/18/2015
57CL99VIRAL VACCINES, N.E.C.
71NO LICENSE
Division of Northeast Imports (DNEI)
12/18/2015
57CL99VIRAL VACCINES, N.E.C.
71NO LICENSE
Division of Northeast Imports (DNEI)
12/18/2015
57CL99VIRAL VACCINES, N.E.C.
71NO LICENSE
Division of Northeast Imports (DNEI)
12/18/2015
57CL99VIRAL VACCINES, N.E.C.
71NO LICENSE
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Crucell Holland Bv's FDA import refusal history?

Crucell Holland Bv (FEI: 3004491997) has 6 FDA import refusal record(s) in our database, spanning from 12/18/2015 to 12/18/2015.

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. Crucell Holland Bv's FEI number is 3004491997.

What types of violations has Crucell Holland Bv received?

Crucell Holland 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 Crucell Holland Bv come from?

All FDA import refusal data for Crucell Holland 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.