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Reform Italia Srl

⚠️ Moderate Risk

FEI: 3006022329 • Endine Gaiano, Bergamo • ITALY

FEI

FEI Number

3006022329

📍

Location

Endine Gaiano, Bergamo

🇮🇹

Country

ITALY
🏢

Address

Via Giorgio Paglia 33, , Endine Gaiano, Bergamo, Italy

Moderate Risk

FDA Import Risk Assessment

48.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/28/2024
Latest Refusal
2/28/2024
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
62.2×20%
Frequency
10.0×10%
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

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
2/28/2024
62FRR99ANTI-INFECTIVE, TOPICAL N.E.C.
72NEW VET DR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Reform Italia Srl's FDA import refusal history?

Reform Italia Srl (FEI: 3006022329) has 1 FDA import refusal record(s) in our database, spanning from 2/28/2024 to 2/28/2024.

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. Reform Italia Srl's FEI number is 3006022329.

What types of violations has Reform Italia Srl received?

Reform Italia Srl 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 Reform Italia Srl come from?

All FDA import refusal data for Reform Italia Srl 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.