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KIRKSTALL PRECISION LIMITED

⚠️ Moderate Risk

FEI: 3014641038 • Leeds • UNITED KINGDOM

FEI

FEI Number

3014641038

📍

Location

Leeds

🇬🇧
🏢

Address

Units G6, G5, G4 Wyther, Leeds, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

37.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/19/2024
Latest Refusal
3/19/2024
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
63.7×20%
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
3/19/2024
87OLOORTHOPEDIC STEREOTAXIC INSTRUMENT
118NOT LISTED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is KIRKSTALL PRECISION LIMITED's FDA import refusal history?

KIRKSTALL PRECISION LIMITED (FEI: 3014641038) has 1 FDA import refusal record(s) in our database, spanning from 3/19/2024 to 3/19/2024.

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. KIRKSTALL PRECISION LIMITED's FEI number is 3014641038.

What types of violations has KIRKSTALL PRECISION LIMITED received?

KIRKSTALL PRECISION LIMITED 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 KIRKSTALL PRECISION LIMITED come from?

All FDA import refusal data for KIRKSTALL PRECISION 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.