Bayer
⚠️ Moderate Risk
FEI: 3002567663 • Pointe-Claire, Quebec • CANADA
FEI Number
3002567663
Location
Pointe-Claire, Quebec
Country
CANADAAddress
7600 Rte Transcanadienne, , Pointe-Claire, Quebec, Canada
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2003 | 60LAB05ASPIRIN (ANALGESIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Bayer's FDA import refusal history?
Bayer (FEI: 3002567663) has 1 FDA import refusal record(s) in our database, spanning from 8/22/2003 to 8/22/2003.
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 3002567663.
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.