Delpharm Milano Srl
⚠️ High Risk
FEI: 3003716872 • Segrate, Milan • ITALY
FEI Number
3003716872
Location
Segrate, Milan
Country
ITALYAddress
Via Carnevali 1, , Segrate, Milan, 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 |
|---|---|---|---|
| 11/13/2025 | 62OCA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/11/2020 | 66MCY75BROMAZEPAM (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/16/2012 | 60RCH18ORLISTAT/TETRAHYDROLIPSTATIN (ANOREXIC) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/24/2007 | 60RAP18ORLISTAT/TETRAHYDROLIPSTATIN (ANOREXIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Delpharm Milano Srl's FDA import refusal history?
Delpharm Milano Srl (FEI: 3003716872) has 4 FDA import refusal record(s) in our database, spanning from 8/24/2007 to 11/13/2025.
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. Delpharm Milano Srl's FEI number is 3003716872.
What types of violations has Delpharm Milano Srl received?
Delpharm Milano Srl 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 Delpharm Milano Srl come from?
All FDA import refusal data for Delpharm Milano 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.