ImportRefusal LogoImportRefusal

Boehringer Ingelheim RCV GmbH & Co KG

⚠️ Moderate Risk

FEI: 3003433722 • Vienna, Vienna • AUSTRIA

FEI

FEI Number

3003433722

📍

Location

Vienna, Vienna

🇦🇹

Country

AUSTRIA
🏢

Address

Dr.-Boehringer-Gasse 5-11, , Vienna, Vienna, Austria

Moderate Risk

FDA Import Risk Assessment

43.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/28/2025
Latest Refusal
10/28/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
95.8×20%
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

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).

Refusal History

DateProductViolationsDivision
10/28/2025
61PCA73EMPAGLIFLOZIN (ANTI-DIABETIC)
118NOT LISTED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Boehringer Ingelheim RCV GmbH & Co KG's FDA import refusal history?

Boehringer Ingelheim RCV GmbH & Co KG (FEI: 3003433722) has 1 FDA import refusal record(s) in our database, spanning from 10/28/2025 to 10/28/2025.

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. Boehringer Ingelheim RCV GmbH & Co KG's FEI number is 3003433722.

What types of violations has Boehringer Ingelheim RCV GmbH & Co KG received?

Boehringer Ingelheim RCV GmbH & Co KG 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 Boehringer Ingelheim RCV GmbH & Co KG come from?

All FDA import refusal data for Boehringer Ingelheim RCV GmbH & Co KG 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.