Bayer
⚠️ Moderate Risk
FEI: 3012152768 • Bogota • COLOMBIA
FEI Number
3012152768
Location
Bogota
Country
COLOMBIAAddress
Cra 58 No 10-76, , Bogota, , Colombia
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/28/2020 | 65JDA39DROSPIRENONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/30/2020 | 60NCL22TESTOSTERONE UNDECANOATE (ANDROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2020 | 64GCA29LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/10/2020 | 64GDA07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2018 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Bayer's FDA import refusal history?
Bayer (FEI: 3012152768) has 5 FDA import refusal record(s) in our database, spanning from 7/24/2018 to 8/28/2020.
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 3012152768.
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.