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Oxford Instruments Medical, LtD.

⚠️ Moderate Risk

FEI: 3002807841 • Woking, Surrey • UNITED KINGDOM

FEI

FEI Number

3002807841

📍

Location

Woking, Surrey

🇬🇧
🏢

Address

Manor Way, , Woking, Surrey, United Kingdom

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/23/2004
Latest Refusal
10/23/2004
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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).

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
10/23/2004
84GXYELECTRODE, CUTANEOUS
118NOT LISTED
126FAILS STD
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Oxford Instruments Medical, LtD.'s FDA import refusal history?

Oxford Instruments Medical, LtD. (FEI: 3002807841) has 1 FDA import refusal record(s) in our database, spanning from 10/23/2004 to 10/23/2004.

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. Oxford Instruments Medical, LtD.'s FEI number is 3002807841.

What types of violations has Oxford Instruments Medical, LtD. received?

Oxford Instruments Medical, LtD. 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 Oxford Instruments Medical, LtD. come from?

All FDA import refusal data for Oxford Instruments Medical, 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.