ImportRefusal LogoImportRefusal

Grunenthal

✅ Low Risk

FEI: 3005729268 • Sint-Stevens-Woluwe, Vlaams-Brabant • BELGIUM

FEI

FEI Number

3005729268

📍

Location

Sint-Stevens-Woluwe, Vlaams-Brabant

🇧🇪

Country

BELGIUM
🏢

Address

Lenneke Marelaan 8, , Sint-Stevens-Woluwe, Vlaams-Brabant, Belgium

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
6/1/2006
Latest Refusal
6/1/2006
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
6/1/2006
60SBY13MAGNESIUM CARBONATE (ANTACID)
472NO ENGLISH
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Grunenthal's FDA import refusal history?

Grunenthal (FEI: 3005729268) has 1 FDA import refusal record(s) in our database, spanning from 6/1/2006 to 6/1/2006.

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. Grunenthal's FEI number is 3005729268.

What types of violations has Grunenthal received?

Grunenthal 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 Grunenthal come from?

All FDA import refusal data for Grunenthal 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.