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Betafarma SPA

⚠️ Moderate Risk

FEI: 3004985762 • Cesano Boscone, Milan • ITALY

FEI

FEI Number

3004985762

📍

Location

Cesano Boscone, Milan

🇮🇹

Country

ITALY
🏢

Address

Via Enrico De Nicola 10, , Cesano Boscone, Milan, Italy

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
10/21/2005
Latest Refusal
9/28/2005
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

2372×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

DateProductViolationsDivision
10/21/2005
78MRESOLUTION, SODIUM HYALURONATE
237NO PMA
New Orleans District Office (NOL-DO)
9/28/2005
78MRESOLUTION, SODIUM HYALURONATE
237NO PMA
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Betafarma SPA's FDA import refusal history?

Betafarma SPA (FEI: 3004985762) has 2 FDA import refusal record(s) in our database, spanning from 9/28/2005 to 10/21/2005.

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. Betafarma SPA's FEI number is 3004985762.

What types of violations has Betafarma SPA received?

Betafarma 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 Betafarma SPA come from?

All FDA import refusal data for Betafarma 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.