ImportRefusal LogoImportRefusal

Owen Mumfordltd.

⚠️ Moderate Risk

FEI: 3000191104 • Oxford, FN • UNITED KINGDOM

FEI

FEI Number

3000191104

📍

Location

Oxford, FN

🇬🇧
🏢

Address

Brook Hill Woodstock, , Oxford, FN, United Kingdom

Moderate Risk

FDA Import Risk Assessment

34.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
10/12/2012
Latest Refusal
1/31/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
11.8×10%
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).

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
10/12/2012
60CCK04EPINEPHRINE (ADRENERGIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/31/2011
79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Owen Mumfordltd.'s FDA import refusal history?

Owen Mumfordltd. (FEI: 3000191104) has 2 FDA import refusal record(s) in our database, spanning from 1/31/2011 to 10/12/2012.

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. Owen Mumfordltd.'s FEI number is 3000191104.

What types of violations has Owen Mumfordltd. received?

Owen Mumfordltd. 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 Owen Mumfordltd. come from?

All FDA import refusal data for Owen Mumfordltd. 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.