Bayer S.P.A.
⚠️ High Risk
FEI: 1000383130 • Milano, MI • ITALY
FEI Number
1000383130
Location
Milano, MI
Country
ITALYAddress
Viale Certosa 126, , Milano, MI, Italy
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 |
|---|---|---|---|
| 11/4/2024 | 65JCY39DROSPIRENONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2019 | 64GDY99ESTROGEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/16/2016 | 54BEA01CALCIUM (MINERAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2014 | 60LAB05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 2/25/2014 | 60SCY99ANTACID, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/26/2013 | 60LDB05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 4/22/2011 | 64GCY27DESOGESTREL/ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/26/2009 | 62GDZ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/14/2004 | 66ACY01HYALURONIDASE (FOR INJECTIONS) (SPREADING AGENT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bayer S.P.A.'s FDA import refusal history?
Bayer S.P.A. (FEI: 1000383130) has 9 FDA import refusal record(s) in our database, spanning from 4/14/2004 to 11/4/2024.
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.P.A.'s FEI number is 1000383130.
What types of violations has Bayer S.P.A. received?
Bayer S.P.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.P.A. come from?
All FDA import refusal data for Bayer S.P.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.