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Qiagen GmbH

⚠️ Moderate Risk

FEI: 3004013603 • Hilden, North Rhine-Westphalia • GERMANY

FEI

FEI Number

3004013603

📍

Location

Hilden, North Rhine-Westphalia

🇩🇪

Country

GERMANY
🏢

Address

Qiagen Str. 1, , Hilden, North Rhine-Westphalia, Germany

Moderate Risk

FDA Import Risk Assessment

33.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
10/9/2025
Latest Refusal
6/10/2019
Earliest Refusal

Score Breakdown

Violation Severity
23.3×40%
Refusal Volume
17.7×30%
Recency
90.3×20%
Frequency
3.2×10%
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

1181×

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).

39041×

3904

39051×

3905

Refusal History

DateProductViolationsDivision
10/9/2025
83QOFMULTI-TARGET RESPIRATORY SPECIMEN NUCLEIC ACID TEST INCLUDING SARS-COV-2 AND OTHER MICROBIAL AGENTS
39043904
39053905
Division of Southeast Imports (DSEI)
6/10/2019
88PPMGENERAL PURPOSE REAGENT
118NOT LISTED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Qiagen GmbH's FDA import refusal history?

Qiagen GmbH (FEI: 3004013603) has 2 FDA import refusal record(s) in our database, spanning from 6/10/2019 to 10/9/2025.

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. Qiagen GmbH's FEI number is 3004013603.

What types of violations has Qiagen GmbH received?

Qiagen GmbH has been cited for 3 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 Qiagen GmbH come from?

All FDA import refusal data for Qiagen 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.