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Fertipro N.V.

⚠️ Moderate Risk

FEI: 3003272500 • Beernem, West-Vlaanderen • BELGIUM

FEI

FEI Number

3003272500

📍

Location

Beernem, West-Vlaanderen

🇧🇪

Country

BELGIUM
🏢

Address

Industriepark Noord 32, , Beernem, West-Vlaanderen, Belgium

Moderate Risk

FDA Import Risk Assessment

26.5
LowModerateHighCritical

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

Statistics

11
Total Refusals
2
Unique Violations
3/22/2013
Latest Refusal
4/30/2002
Earliest Refusal

Score Breakdown

Violation Severity
33.6×40%
Refusal Volume
40.0×30%
Recency
0.0×20%
Frequency
10.1×10%
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

3419×

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).

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).

Refusal History

DateProductViolationsDivision
3/22/2013
85MQLMEDIA, REPRODUCTIVE
341REGISTERED
New Orleans District Office (NOL-DO)
3/22/2013
85MQLMEDIA, REPRODUCTIVE
341REGISTERED
New Orleans District Office (NOL-DO)
3/22/2013
85MQLMEDIA, REPRODUCTIVE
341REGISTERED
New Orleans District Office (NOL-DO)
3/22/2013
85MQLMEDIA, REPRODUCTIVE
341REGISTERED
New Orleans District Office (NOL-DO)
3/22/2013
85MQLMEDIA, REPRODUCTIVE
341REGISTERED
New Orleans District Office (NOL-DO)
3/22/2013
85MQLMEDIA, REPRODUCTIVE
341REGISTERED
New Orleans District Office (NOL-DO)
3/22/2013
85MQLMEDIA, REPRODUCTIVE
341REGISTERED
New Orleans District Office (NOL-DO)
3/22/2013
85MQLMEDIA, REPRODUCTIVE
341REGISTERED
New Orleans District Office (NOL-DO)
3/22/2013
85MQLMEDIA, REPRODUCTIVE
341REGISTERED
New Orleans District Office (NOL-DO)
8/22/2002
88HZTREAGENT, SCHIFF
118NOT LISTED
New Orleans District Office (NOL-DO)
4/30/2002
88LDTREAGENT, GENERAL PURPOSE
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Fertipro N.V.'s FDA import refusal history?

Fertipro N.V. (FEI: 3003272500) has 11 FDA import refusal record(s) in our database, spanning from 4/30/2002 to 3/22/2013.

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. Fertipro N.V.'s FEI number is 3003272500.

What types of violations has Fertipro N.V. received?

Fertipro N.V. has been cited for 2 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 Fertipro N.V. come from?

All FDA import refusal data for Fertipro N.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.