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Cermak

⚠️ Moderate Risk

FEI: 3006520588 • Pforceim • GERMANY

FEI

FEI Number

3006520588

📍

Location

Pforceim

🇩🇪

Country

GERMANY
🏢

Address

Maximilanstr 16a, , Pforceim, , 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
11/5/2007
Latest Refusal
11/5/2007
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
11/5/2007
95L22LASER PRODUCT FOR NON-MEDICAL USE
47NON STD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Cermak's FDA import refusal history?

Cermak (FEI: 3006520588) has 1 FDA import refusal record(s) in our database, spanning from 11/5/2007 to 11/5/2007.

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. Cermak's FEI number is 3006520588.

What types of violations has Cermak received?

Cermak 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 Cermak come from?

All FDA import refusal data for Cermak 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.