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Stuart Finlay

⚠️ Moderate Risk

FEI: 3008533401 • Rhiwbina Cardiff • UNITED KINGDOM

FEI

FEI Number

3008533401

📍

Location

Rhiwbina Cardiff

🇬🇧
🏢

Address

42h Heol Llanishen Fach, , Rhiwbina Cardiff, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

38.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
11/2/2010
Latest Refusal
11/2/2010
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
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

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

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
11/2/2010
61PDK17INSULIN (INJ) (ANTI-DIABETIC)
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Stuart Finlay's FDA import refusal history?

Stuart Finlay (FEI: 3008533401) has 1 FDA import refusal record(s) in our database, spanning from 11/2/2010 to 11/2/2010.

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. Stuart Finlay's FEI number is 3008533401.

What types of violations has Stuart Finlay received?

Stuart Finlay 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 Stuart Finlay come from?

All FDA import refusal data for Stuart Finlay 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.