Bayer S.A.
⚠️ Moderate Risk
FEI: 3005203073 • Unknown • GUATEMALA
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
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/20/2017 | 60LBA01ACETAMINOPHEN (ANALGESIC) | 344WARNINGS | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Bayer S.A.'s FDA import refusal history?
Bayer S.A. (FEI: 3005203073) has 1 FDA import refusal record(s) in our database, spanning from 3/20/2017 to 3/20/2017.
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.A.'s FEI number is 3005203073.
What types of violations has Bayer S.A. received?
Bayer S.A. 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 S.A. come from?
All FDA import refusal data for Bayer S.A. 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.