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Bayer Healthcare Ag

⚠️ High Risk

FEI: 3009044483 • Leverkusen, Nordrhein-westfalen • GERMANY

FEI

FEI Number

3009044483

📍

Location

Leverkusen, Nordrhein-westfalen

🇩🇪

Country

GERMANY
🏢

Address

Kaiser-Wilhelm-Allee 1, , Leverkusen, Nordrhein-westfalen, Germany

High Risk

FDA Import Risk Assessment

54.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

3
Total Refusals
1
Unique Violations
9/20/2024
Latest Refusal
6/15/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
58.8×20%
Frequency
2.4×10%
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

753×

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
9/20/2024
61LCC42RIVAROXABAN
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/13/2023
65JCY39DROSPIRENONE
75UNAPPROVED
Division of Northern Border Imports (DNBI)
6/15/2012
60LCA05ASPIRIN (ANALGESIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Bayer Healthcare Ag's FDA import refusal history?

Bayer Healthcare Ag (FEI: 3009044483) has 3 FDA import refusal record(s) in our database, spanning from 6/15/2012 to 9/20/2024.

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. Bayer Healthcare Ag's FEI number is 3009044483.

What types of violations has Bayer Healthcare Ag received?

Bayer Healthcare Ag 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 Bayer Healthcare Ag come from?

All FDA import refusal data for Bayer Healthcare Ag 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.