ImportRefusal LogoImportRefusal

Grunenthal GmbH

⚠️ Moderate Risk

FEI: 3002807105 • Aachen, North Rhine-Westphalia • GERMANY

FEI

FEI Number

3002807105

📍

Location

Aachen, North Rhine-Westphalia

🇩🇪

Country

GERMANY
🏢

Address

Zieglerstr. 6, , Aachen, North Rhine-Westphalia, Germany

Moderate Risk

FDA Import Risk Assessment

44.1
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
10/12/2018
Latest Refusal
6/7/2005
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
3.0×10%
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

754×

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
10/12/2018
65VCY40THALIDOMIDE (SEDATIVE)
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/13/2007
60LIY69TRAMADOL HCL (ANALGESIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
5/25/2006
64GIA07ESTRADIOL (ESTROGEN)
75UNAPPROVED
New Orleans District Office (NOL-DO)
6/7/2005
61XAB99ANTI-HISTAMINIC N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Grunenthal GmbH's FDA import refusal history?

Grunenthal GmbH (FEI: 3002807105) has 4 FDA import refusal record(s) in our database, spanning from 6/7/2005 to 10/12/2018.

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 GmbH's FEI number is 3002807105.

What types of violations has Grunenthal GmbH received?

Grunenthal GmbH 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 GmbH come from?

All FDA import refusal data for Grunenthal GmbH 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.