Malesci Istituto Farmacobiologic
⚠️ Moderate Risk
FEI: 3005001030 • Bagno a Ripoli, Florence • ITALY
FEI Number
3005001030
Location
Bagno a Ripoli, Florence
Country
ITALYAddress
Via Lungo L'Ema 7, , Bagno a Ripoli, Florence, 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).
Refusal History
Frequently Asked Questions
What is Malesci Istituto Farmacobiologic's FDA import refusal history?
Malesci Istituto Farmacobiologic (FEI: 3005001030) has 2 FDA import refusal record(s) in our database, spanning from 7/11/2016 to 11/9/2017.
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. Malesci Istituto Farmacobiologic's FEI number is 3005001030.
What types of violations has Malesci Istituto Farmacobiologic received?
Malesci Istituto Farmacobiologic 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 Malesci Istituto Farmacobiologic come from?
All FDA import refusal data for Malesci Istituto Farmacobiologic 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.