Zach System S.P.A. (Zambon Group Spa)
⚠️ Moderate Risk
FEI: 1000280098 • Bresso, Milan • ITALY
FEI Number
1000280098
Location
Bresso, Milan
Country
ITALYAddress
Via Lillo del Duca 10, , Bresso, Milan, 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/5/2012 | 62OCS26DORZOLAMIDE HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/5/2012 | 62OCS26DORZOLAMIDE HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/5/2012 | 62OCS26DORZOLAMIDE HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/5/2012 | 62OCS26DORZOLAMIDE HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/25/2008 | 62GCS70SULINDAC (ANTI-INFLAMMATORY) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/2/2007 | 61WDP44ECONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Zach System S.P.A. (Zambon Group Spa)'s FDA import refusal history?
Zach System S.P.A. (Zambon Group Spa) (FEI: 1000280098) has 6 FDA import refusal record(s) in our database, spanning from 5/2/2007 to 11/5/2012.
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. Zach System S.P.A. (Zambon Group Spa)'s FEI number is 1000280098.
What types of violations has Zach System S.P.A. (Zambon Group Spa) received?
Zach System S.P.A. (Zambon Group 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 Zach System S.P.A. (Zambon Group Spa) come from?
All FDA import refusal data for Zach System S.P.A. (Zambon Group 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.