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Glaxosmith Kline Mfg Spa Unip

⚠️ Moderate Risk

FEI: 3011531523 • Verona, Verona • ITALY

FEI

FEI Number

3011531523

📍

Location

Verona, Verona

🇮🇹

Country

ITALY
🏢

Address

Via Alessandro Fleming 2, , Verona, Verona, Italy

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/6/2020
Latest Refusal
5/6/2020
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

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
5/6/2020
63BCY02ALBUTEROL SULFATE (BRONCHODILATOR)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Glaxosmith Kline Mfg Spa Unip's FDA import refusal history?

Glaxosmith Kline Mfg Spa Unip (FEI: 3011531523) has 1 FDA import refusal record(s) in our database, spanning from 5/6/2020 to 5/6/2020.

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. Glaxosmith Kline Mfg Spa Unip's FEI number is 3011531523.

What types of violations has Glaxosmith Kline Mfg Spa Unip received?

Glaxosmith Kline Mfg Spa Unip 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 Glaxosmith Kline Mfg Spa Unip come from?

All FDA import refusal data for Glaxosmith Kline Mfg Spa Unip 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.