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ALFASIGMA SPA

⚠️ Moderate Risk

FEI: 3013859613 • Milan, Milan • ITALY

FEI

FEI Number

3013859613

📍

Location

Milan, Milan

🇮🇹

Country

ITALY
🏢

Address

Viale Sarca 223, , Milan, Milan, Italy

Moderate Risk

FDA Import Risk Assessment

47.5
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

6
Total Refusals
1
Unique Violations
9/25/2020
Latest Refusal
11/9/2017
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
20.8×10%
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

756×

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

DateProductViolationsDivision
9/25/2020
61VCA99ANTI-FLATULENT N.E.C.
75UNAPPROVED
Division of Northern Border Imports (DNBI)
2/21/2019
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/21/2019
64LCY03BETAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/21/2019
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/21/2019
64LCY03BETAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/9/2017
54HCF05OMEGA-3 (FATS AND LIPID SUBSTANCES)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ALFASIGMA SPA's FDA import refusal history?

ALFASIGMA SPA (FEI: 3013859613) has 6 FDA import refusal record(s) in our database, spanning from 11/9/2017 to 9/25/2020.

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 3013859613.

What types of violations has ALFASIGMA SPA received?

ALFASIGMA 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 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.