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Vectura Ltd

⚠️ Moderate Risk

FEI: 3008702754 • Chippenham, Wiltshire • UNITED KINGDOM

FEI

FEI Number

3008702754

📍

Location

Chippenham, Wiltshire

🇬🇧
🏢

Address

Unit 1, Prospect West; Bumpers Way, Chippenham, Wiltshire, United Kingdom

Moderate Risk

FDA Import Risk Assessment

37.8
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
1/23/2012
Latest Refusal
5/6/2008
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
5.4×10%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

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
1/23/2012
63BDR25FLUTICASONE PROPIONATE (BRONCHODILATOR)
16DIRECTIONS
Chicago District Office (CHI-DO)
5/6/2008
63BIY25FLUTICASONE PROPIONATE (BRONCHODILATOR)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Vectura Ltd's FDA import refusal history?

Vectura Ltd (FEI: 3008702754) has 2 FDA import refusal record(s) in our database, spanning from 5/6/2008 to 1/23/2012.

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. Vectura Ltd's FEI number is 3008702754.

What types of violations has Vectura Ltd received?

Vectura Ltd has been cited for 2 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 Vectura Ltd come from?

All FDA import refusal data for Vectura Ltd 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.