Mylan Spa
⚠️ High Risk
FEI: 3008022197 • Milan, Milan • ITALY
FEI Number
3008022197
Location
Milan, Milan
Country
ITALYAddress
Via Vittor Pisani 20, , Milan, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/13/2025 | 66MCY86LORAZEPAM (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2024 | 56YCY99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/6/2019 | 62GCY41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2019 | 61NCA83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2019 | 63OCA06SUMATRIPTAN (ANTIMIGRAINE AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2019 | 61HCA43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2019 | 63ECA29TICLOPIDINE HYDROCHLORIDE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2019 | 61FCA56CLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2019 | 62ODA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2019 | 61CNY99ANTI-ANEMIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2018 | 61WDB47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/11/2016 | 61PCY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 7/11/2016 | 61JCB13PRAVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/2/2016 | 61WDJ45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/26/2013 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 10/18/2011 | 62VCS99ANTI-VIRAL N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/18/2011 | 62VCS99ANTI-VIRAL N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mylan Spa's FDA import refusal history?
Mylan Spa (FEI: 3008022197) has 17 FDA import refusal record(s) in our database, spanning from 10/18/2011 to 8/13/2025.
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. Mylan Spa's FEI number is 3008022197.
What types of violations has Mylan Spa received?
Mylan Spa has been cited for 2 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 Mylan Spa come from?
All FDA import refusal data for Mylan Spa 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.