Roche Diagnotics Spa
⚠️ Moderate Risk
FEI: 3002735804 • Monza • ITALY
FEI Number
3002735804
Location
Monza
Country
ITALYAddress
Viale Gian Battista Stucchi 110, , Monza, , 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 Roche Diagnotics Spa's FDA import refusal history?
Roche Diagnotics Spa (FEI: 3002735804) has 2 FDA import refusal record(s) in our database, spanning from 10/12/2007 to 1/9/2009.
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. Roche Diagnotics Spa's FEI number is 3002735804.
What types of violations has Roche Diagnotics Spa received?
Roche Diagnotics Spa 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 Roche Diagnotics Spa come from?
All FDA import refusal data for Roche Diagnotics 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.