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TUR RONTGENTECHNIK

⚠️ Moderate Risk

FEI: 3014667205 • Oitsdan • GERMANY

FEI

FEI Number

3014667205

📍

Location

Oitsdan

🇩🇪

Country

GERMANY
🏢

Address

Fr Ebert Str 69, , Oitsdan, , Germany

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/11/2018
Latest Refusal
10/11/2018
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

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
10/11/2018
90IYBTUBE MOUNT, X-RAY, DIAGNOSTIC
47NON STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is TUR RONTGENTECHNIK's FDA import refusal history?

TUR RONTGENTECHNIK (FEI: 3014667205) has 1 FDA import refusal record(s) in our database, spanning from 10/11/2018 to 10/11/2018.

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. TUR RONTGENTECHNIK's FEI number is 3014667205.

What types of violations has TUR RONTGENTECHNIK received?

TUR RONTGENTECHNIK 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 TUR RONTGENTECHNIK come from?

All FDA import refusal data for TUR RONTGENTECHNIK 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.