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Advanced Medical Solutions Limited

⚠️ Moderate Risk

FEI: 3010571423 • Plymouth • UNITED KINGDOM

FEI

FEI Number

3010571423

📍

Location

Plymouth

🇬🇧
🏢

Address

Western Wood Way, Langage Science Park, Plymouth, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

26.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/22/2023
Latest Refusal
6/22/2023
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
48.8×20%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
6/22/2023
79MPNTISSUE ADHESIVE FOR SOFT TISSUE APPROXIMATION
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Advanced Medical Solutions Limited's FDA import refusal history?

Advanced Medical Solutions Limited (FEI: 3010571423) has 1 FDA import refusal record(s) in our database, spanning from 6/22/2023 to 6/22/2023.

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. Advanced Medical Solutions Limited's FEI number is 3010571423.

What types of violations has Advanced Medical Solutions Limited received?

Advanced Medical Solutions 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 Advanced Medical Solutions Limited come from?

All FDA import refusal data for Advanced Medical Solutions 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.