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Dafra Pharma N.V. SA

⚠️ Moderate Risk

FEI: 3003833256 • Turnhout, Antwerp • BELGIUM

FEI

FEI Number

3003833256

📍

Location

Turnhout, Antwerp

🇧🇪

Country

BELGIUM
🏢

Address

2360 Oud, Steenweg Op Mol 148, Turnhout, Antwerp, Belgium

Moderate Risk

FDA Import Risk Assessment

43.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
12/28/2005
Latest Refusal
1/21/2003
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
10.2×10%
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

753×

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
12/28/2005
66VCB99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/28/2005
66VCB99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
1/21/2003
62LCA99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Dafra Pharma N.V. SA's FDA import refusal history?

Dafra Pharma N.V. SA (FEI: 3003833256) has 3 FDA import refusal record(s) in our database, spanning from 1/21/2003 to 12/28/2005.

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. Dafra Pharma N.V. SA's FEI number is 3003833256.

What types of violations has Dafra Pharma N.V. SA received?

Dafra Pharma N.V. SA 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 Dafra Pharma N.V. SA come from?

All FDA import refusal data for Dafra Pharma N.V. SA 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.