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Activesignal Ltd

⚠️ Moderate Risk

FEI: 3010077419 • Abergele • UNITED KINGDOM

FEI

FEI Number

3010077419

📍

Location

Abergele

🇬🇧
🏢

Address

North Wales Business Park, , Abergele, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
5/10/2013
Latest Refusal
5/10/2013
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
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

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

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
5/10/2013
68KYY02HORSES WOUND DRESSING
335LACKS N/C
336INCONSPICU
72NEW VET DR
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Activesignal Ltd's FDA import refusal history?

Activesignal Ltd (FEI: 3010077419) has 1 FDA import refusal record(s) in our database, spanning from 5/10/2013 to 5/10/2013.

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. Activesignal Ltd's FEI number is 3010077419.

What types of violations has Activesignal Ltd received?

Activesignal Ltd has been cited for 3 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 Activesignal Ltd come from?

All FDA import refusal data for Activesignal 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.