ImportRefusal LogoImportRefusal

FARMACIA LORETO GALLO

⚠️ Moderate Risk

FEI: 3012380478 • Naples, Naples • ITALY

FEI

FEI Number

3012380478

📍

Location

Naples, Naples

🇮🇹

Country

ITALY
🏢

Address

Via Michelangelo Schipa, , Naples, Naples, Italy

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/9/2016
Latest Refusal
9/9/2016
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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
9/9/2016
72YHT99PET/LAB ANIMAL FOOD, N.E.C.
72NEW VET DR
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is FARMACIA LORETO GALLO's FDA import refusal history?

FARMACIA LORETO GALLO (FEI: 3012380478) has 1 FDA import refusal record(s) in our database, spanning from 9/9/2016 to 9/9/2016.

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. FARMACIA LORETO GALLO's FEI number is 3012380478.

What types of violations has FARMACIA LORETO GALLO received?

FARMACIA LORETO GALLO 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 FARMACIA LORETO GALLO come from?

All FDA import refusal data for FARMACIA LORETO GALLO 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.