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Vitafor NV

⚠️ Moderate Risk

FEI: 3006222820 • Sint-Niklaas, Oost-Vlaanderen • BELGIUM

FEI

FEI Number

3006222820

📍

Location

Sint-Niklaas, Oost-Vlaanderen

🇧🇪

Country

BELGIUM
🏢

Address

Industriepark-Noord 18-19, , Sint-Niklaas, Oost-Vlaanderen, Belgium

Moderate Risk

FDA Import Risk Assessment

41.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
4
Unique Violations
11/16/2010
Latest Refusal
9/20/2010
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

1992×

FEED & NAD

The article appears to be an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of section 512.

722×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

752×

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
11/16/2010
67A63VIRGINIAMYCIN CATEGORY I, TYPE A MEDICATED ARTICLE
75UNAPPROVED
Chicago District Office (CHI-DO)
11/16/2010
67A63VIRGINIAMYCIN CATEGORY I, TYPE A MEDICATED ARTICLE
75UNAPPROVED
Chicago District Office (CHI-DO)
9/20/2010
69AA63VIRGINIAMYCIN CATEGORY I, MEDICATED ANIMAL FEED
118NOT LISTED
199FEED & NAD
72NEW VET DR
Chicago District Office (CHI-DO)
9/20/2010
69AA63VIRGINIAMYCIN CATEGORY I, MEDICATED ANIMAL FEED
118NOT LISTED
199FEED & NAD
72NEW VET DR
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Vitafor NV's FDA import refusal history?

Vitafor NV (FEI: 3006222820) has 4 FDA import refusal record(s) in our database, spanning from 9/20/2010 to 11/16/2010.

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. Vitafor NV's FEI number is 3006222820.

What types of violations has Vitafor NV received?

Vitafor NV has been cited for 4 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 Vitafor NV come from?

All FDA import refusal data for Vitafor NV 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.