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Farla Medical Limited

⚠️ Moderate Risk

FEI: 3008297558 • London • UNITED KINGDOM

FEI

FEI Number

3008297558

📍

Location

London

🇬🇧
🏢

Address

Ut7,Interchange East Indestat, , London, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

27.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
1/12/2016
Latest Refusal
8/5/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
6.8×10%
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

1183×

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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
1/12/2016
79GESBLADE, SCALPEL
118NOT LISTED
3280FRNMFGREG
New Orleans District Office (NOL-DO)
10/18/2011
79GESBLADE, SCALPEL
118NOT LISTED
New Orleans District Office (NOL-DO)
8/5/2011
79GESBLADE, SCALPEL
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Farla Medical Limited's FDA import refusal history?

Farla Medical Limited (FEI: 3008297558) has 3 FDA import refusal record(s) in our database, spanning from 8/5/2011 to 1/12/2016.

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. Farla Medical Limited's FEI number is 3008297558.

What types of violations has Farla Medical Limited received?

Farla Medical Limited 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 Farla Medical Limited come from?

All FDA import refusal data for Farla Medical Limited 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.