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Centra Burkle Gmbh

⚠️ Moderate Risk

FEI: 3004039894 • Schonaich, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3004039894

📍

Location

Schonaich, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Postfach 1164, , Schonaich, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/26/2003
Latest Refusal
6/26/2003
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
6/26/2003
95U19SUNLAMP PRODUCT (PRE-STANDARD) FOR NON-MEDICAL USE
476NO REGISTR
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Centra Burkle Gmbh's FDA import refusal history?

Centra Burkle Gmbh (FEI: 3004039894) has 1 FDA import refusal record(s) in our database, spanning from 6/26/2003 to 6/26/2003.

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. Centra Burkle Gmbh's FEI number is 3004039894.

What types of violations has Centra Burkle Gmbh received?

Centra Burkle Gmbh 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 Centra Burkle Gmbh come from?

All FDA import refusal data for Centra Burkle Gmbh 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.