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Bull Rubber Limited

⚠️ Moderate Risk

FEI: 3004585467 • Tewkesbury • UNITED KINGDOM

FEI

FEI Number

3004585467

📍

Location

Tewkesbury

🇬🇧
🏢

Address

Rectory Works Fiddington, , Tewkesbury, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

31.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
8/23/2006
Latest Refusal
2/16/2006
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

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).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
8/23/2006
77KBARASP, NASAL
118NOT LISTED
New Orleans District Office (NOL-DO)
8/22/2006
85HDWDIAPHRAGM, CONTRACEPTIVE (AND ACCESSORIES)
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
2/16/2006
73CATCANNULA, NASAL, OXYGEN
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Bull Rubber Limited's FDA import refusal history?

Bull Rubber Limited (FEI: 3004585467) has 3 FDA import refusal record(s) in our database, spanning from 2/16/2006 to 8/23/2006.

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. Bull Rubber Limited's FEI number is 3004585467.

What types of violations has Bull Rubber Limited received?

Bull Rubber 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 Bull Rubber Limited come from?

All FDA import refusal data for Bull Rubber 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.