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Bayer

⚠️ Moderate Risk

FEI: 3002696004 • St Clements, Ontario • CANADA

FEI

FEI Number

3002696004

📍

Location

St Clements, Ontario

🇨🇦

Country

CANADA
🏢

Address

35 Park St, , St Clements, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
11/14/2001
Latest Refusal
10/30/2001
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

752×

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
11/14/2001
61FBB54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
New York District Office (NYK-DO)
10/30/2001
61FBB54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Bayer's FDA import refusal history?

Bayer (FEI: 3002696004) has 2 FDA import refusal record(s) in our database, spanning from 10/30/2001 to 11/14/2001.

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's FEI number is 3002696004.

What types of violations has Bayer received?

Bayer 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 come from?

All FDA import refusal data for Bayer 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.