Rottapharm S.p.A.
⚠️ Moderate Risk
FEI: 3005060794 • Monza, Monza E della Brianza • ITALY
FEI Number
3005060794
Location
Monza, Monza E della Brianza
Country
ITALYAddress
Via Valosa Di Sopra 9, , Monza, Monza E della Brianza, 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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/25/2014 | 61XCY99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/14/2006 | 65CCY04BETAINE ANHYDROUS (NUTRIENT/TONIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/21/2005 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Rottapharm S.p.A.'s FDA import refusal history?
Rottapharm S.p.A. (FEI: 3005060794) has 3 FDA import refusal record(s) in our database, spanning from 12/21/2005 to 2/25/2014.
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. Rottapharm S.p.A.'s FEI number is 3005060794.
What types of violations has Rottapharm S.p.A. received?
Rottapharm S.p.A. 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 Rottapharm S.p.A. come from?
All FDA import refusal data for Rottapharm S.p.A. 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.