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Bayer Diagnostics

⚠️ Moderate Risk

FEI: 3003767563 • Cergy Pontois • FRANCE

FEI

FEI Number

3003767563

📍

Location

Cergy Pontois

🇫🇷

Country

FRANCE
🏢

Address

Bp 109 Eragny, , Cergy Pontois, , France

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/15/2002
Latest Refusal
10/15/2002
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

1861×

INSANITARY

The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
10/15/2002
88LDTREAGENT, GENERAL PURPOSE
186INSANITARY
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Bayer Diagnostics's FDA import refusal history?

Bayer Diagnostics (FEI: 3003767563) has 1 FDA import refusal record(s) in our database, spanning from 10/15/2002 to 10/15/2002.

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 Diagnostics's FEI number is 3003767563.

What types of violations has Bayer Diagnostics received?

Bayer Diagnostics 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 Diagnostics come from?

All FDA import refusal data for Bayer Diagnostics 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.