ImportRefusal LogoImportRefusal

FCL Health Solutions Ltd

✅ Low Risk

FEI: 3010871823 • Smethwick, West Midlands • UNITED KINGDOM

FEI

FEI Number

3010871823

📍

Location

Smethwick, West Midlands

🇬🇧
🏢

Address

Hawthorns House, Hawthorns Business Centre; Halfords Lane, Smethwick, West Midlands, United Kingdom

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
5/17/2018
Latest Refusal
5/17/2018
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
5/17/2018
79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
118NOT LISTED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is FCL Health Solutions Ltd's FDA import refusal history?

FCL Health Solutions Ltd (FEI: 3010871823) has 1 FDA import refusal record(s) in our database, spanning from 5/17/2018 to 5/17/2018.

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. FCL Health Solutions Ltd's FEI number is 3010871823.

What types of violations has FCL Health Solutions Ltd received?

FCL Health Solutions Ltd 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 FCL Health Solutions Ltd come from?

All FDA import refusal data for FCL Health Solutions 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.