Bayer Healthcare Manufacturing Srl
⚠️ Moderate Risk
FEI: 3002806461 • Garbagnate Milanese, Milan • ITALY
FEI Number
3002806461
Location
Garbagnate Milanese, Milan
Country
ITALYAddress
Via Delle Groane 126, , Garbagnate Milanese, Milan, Italy
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/11/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2015 | 62GAY41IBUPROFEN (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 11/25/2015 | 60LAY05ASPIRIN (ANALGESIC) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Bayer Healthcare Manufacturing Srl's FDA import refusal history?
Bayer Healthcare Manufacturing Srl (FEI: 3002806461) has 3 FDA import refusal record(s) in our database, spanning from 11/25/2015 to 7/11/2024.
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 Healthcare Manufacturing Srl's FEI number is 3002806461.
What types of violations has Bayer Healthcare Manufacturing Srl received?
Bayer Healthcare Manufacturing Srl has been cited for 3 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 Healthcare Manufacturing Srl come from?
All FDA import refusal data for Bayer Healthcare Manufacturing Srl 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.