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RALF ZIEGLER

⚠️ Moderate Risk

FEI: 3021442837 • St. Martin, Rhineland-Palatinate • GERMANY

FEI

FEI Number

3021442837

📍

Location

St. Martin, Rhineland-Palatinate

🇩🇪

Country

GERMANY
🏢

Address

Edenkobener Str. 40, , St. Martin, Rhineland-Palatinate, Germany

Moderate Risk

FDA Import Risk Assessment

33.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/14/2022
Latest Refusal
2/14/2022
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
7.8×20%
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

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
2/14/2022
88PPMGENERAL PURPOSE REAGENT
508NO 510(K)
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is RALF ZIEGLER's FDA import refusal history?

RALF ZIEGLER (FEI: 3021442837) has 1 FDA import refusal record(s) in our database, spanning from 2/14/2022 to 2/14/2022.

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. RALF ZIEGLER's FEI number is 3021442837.

What types of violations has RALF ZIEGLER received?

RALF ZIEGLER 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 RALF ZIEGLER come from?

All FDA import refusal data for RALF ZIEGLER 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.