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OXFORD MEDICAL INSTRUMENTS HUN

⚠️ Moderate Risk

FEI: 3019708625 • Szentendre, Pest • HUNGARY

FEI

FEI Number

3019708625

📍

Location

Szentendre, Pest

🇭🇺

Country

HUNGARY
🏢

Address

Rozsa Utca 8, , Szentendre, Pest, Hungary

Moderate Risk

FDA Import Risk Assessment

43.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/6/2023
Latest Refusal
10/6/2023
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
54.1×20%
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
10/6/2023
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is OXFORD MEDICAL INSTRUMENTS HUN's FDA import refusal history?

OXFORD MEDICAL INSTRUMENTS HUN (FEI: 3019708625) has 1 FDA import refusal record(s) in our database, spanning from 10/6/2023 to 10/6/2023.

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. OXFORD MEDICAL INSTRUMENTS HUN's FEI number is 3019708625.

What types of violations has OXFORD MEDICAL INSTRUMENTS HUN received?

OXFORD MEDICAL INSTRUMENTS HUN 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 OXFORD MEDICAL INSTRUMENTS HUN come from?

All FDA import refusal data for OXFORD MEDICAL INSTRUMENTS HUN 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.