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Bayers Inc.

⚠️ Moderate Risk

FEI: 3003470968 • Etobicoke, ON • CANADA

FEI

FEI Number

3003470968

📍

Location

Etobicoke, ON

🇨🇦

Country

CANADA
🏢

Address

Box 1000, Station B, , Etobicoke, ON, Canada

Moderate Risk

FDA Import Risk Assessment

40.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
12/5/2002
Latest Refusal
10/31/2001
Earliest Refusal

Score Breakdown

Violation Severity
83.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
18.3×10%
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).

3421×

PERSONALRX

The article appears to be a drug which requires a prescription from your doctor.

Refusal History

DateProductViolationsDivision
12/5/2002
66VDA99MISCELLANEOUS PATENT MEDICINES, ETC.
342PERSONALRX
75UNAPPROVED
Detroit District Office (DET-DO)
10/31/2001
61FCY55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Bayers Inc.'s FDA import refusal history?

Bayers Inc. (FEI: 3003470968) has 2 FDA import refusal record(s) in our database, spanning from 10/31/2001 to 12/5/2002.

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. Bayers Inc.'s FEI number is 3003470968.

What types of violations has Bayers Inc. received?

Bayers Inc. has been cited for 2 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 Bayers Inc. come from?

All FDA import refusal data for Bayers Inc. 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.