Mediolast Spa
⚠️ Moderate Risk
FEI: 1000262107 • Milano, MI • ITALY
FEI Number
1000262107
Location
Milano, MI
Country
ITALYAddress
Via Montenapoleone 9, , Milano, MI, 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
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.
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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 |
|---|---|---|---|
| 3/28/2007 | 61WCZ43CICLOPIROX (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/22/2005 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/30/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mediolast Spa's FDA import refusal history?
Mediolast Spa (FEI: 1000262107) has 3 FDA import refusal record(s) in our database, spanning from 1/30/2002 to 3/28/2007.
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. Mediolast Spa's FEI number is 1000262107.
What types of violations has Mediolast Spa received?
Mediolast Spa 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 Mediolast Spa come from?
All FDA import refusal data for Mediolast 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.