Nieves Lenzi Tirapani
⚠️ Moderate Risk
FEI: 3005429968 • Imola, Bologna • ITALY
FEI Number
3005429968
Location
Imola, Bologna
Country
ITALYAddress
Via Selice 98, , Imola, Bologna, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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 |
|---|---|---|---|
| 12/21/2005 | 61NCY81RIVASTIGMINE TARTRATE (ANTI-DEPRESSANT) | New York District Office (NYK-DO) | |
| 12/21/2005 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | New York District Office (NYK-DO) | |
| 12/21/2005 | 64BCE25HYDROCHLOROTHIAZIDE (DIURETIC) | New York District Office (NYK-DO) | |
| 12/21/2005 | 62OAA19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Nieves Lenzi Tirapani's FDA import refusal history?
Nieves Lenzi Tirapani (FEI: 3005429968) has 4 FDA import refusal record(s) in our database, spanning from 12/21/2005 to 12/21/2005.
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. Nieves Lenzi Tirapani's FEI number is 3005429968.
What types of violations has Nieves Lenzi Tirapani received?
Nieves Lenzi Tirapani 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 Nieves Lenzi Tirapani come from?
All FDA import refusal data for Nieves Lenzi Tirapani 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.