Alfasigma SPA
⚠️ High Risk
FEI: 3003911081 • Alanno • ITALY
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/3/2023 | 61LDY22ANTI-COAGULANT HEPARIN SOL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2022 | 61FCA63RIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 12/16/2021 | 65QAY99RELAXANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2017 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/16/2011 | 64GDA07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/17/2006 | 56YCC99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/27/2005 | 63XDY99DIAGOSTIC AID (DRUGS) N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Alfasigma SPA's FDA import refusal history?
Alfasigma SPA (FEI: 3003911081) has 7 FDA import refusal record(s) in our database, spanning from 12/27/2005 to 10/3/2023.
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. Alfasigma SPA's FEI number is 3003911081.
What types of violations has Alfasigma SPA received?
Alfasigma SPA 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 Alfasigma SPA come from?
All FDA import refusal data for Alfasigma 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.