Bayer Inc
⚠️ Moderate Risk
FEI: 3001443914 • Etobicoke, ON • CANADA
FEI Number
3001443914
Location
Etobicoke, ON
Country
CANADAAddress
Agfa Division 77 Belfield Road, , Etobicoke, ON, 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
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).
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/28/2016 | 61WCO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/11/2012 | 66SCB27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/26/2012 | 66SCB27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/15/2011 | 54AYC99VITAMIN, N.E.C. | 218LIST INGRE | New Orleans District Office (NOL-DO) |
| 3/15/2011 | 66SCB27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/23/2011 | 66SCB27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 66SCP27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 66SCP27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 66SCP27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/19/2004 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/19/2004 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/19/2004 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/24/2004 | 63XIP99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/26/2001 | 56YAY99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Bayer Inc's FDA import refusal history?
Bayer Inc (FEI: 3001443914) has 14 FDA import refusal record(s) in our database, spanning from 10/26/2001 to 7/28/2016.
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 Inc's FEI number is 3001443914.
What types of violations has Bayer Inc received?
Bayer 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 Bayer Inc come from?
All FDA import refusal data for Bayer 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.