ImportRefusal LogoImportRefusal

Caesar und Loretz GmbH

⚠️ Moderate Risk

FEI: 3008320803 • Bonn, North Rhine-Westphalia • GERMANY

FEI

FEI Number

3008320803

📍

Location

Bonn, North Rhine-Westphalia

🇩🇪

Country

GERMANY
🏢

Address

Rohfeldstr. 46, , Bonn, North Rhine-Westphalia, Germany

Moderate Risk

FDA Import Risk Assessment

30.8
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/15/2014
Latest Refusal
10/8/2002
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
1.7×10%
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

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
7/15/2014
63EIY18ADENOSINE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC))
16DIRECTIONS
Division of Northern Border Imports (DNBI)
10/8/2002
62VCS99ANTI-VIRAL N.E.C.
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Caesar und Loretz GmbH's FDA import refusal history?

Caesar und Loretz GmbH (FEI: 3008320803) has 2 FDA import refusal record(s) in our database, spanning from 10/8/2002 to 7/15/2014.

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. Caesar und Loretz GmbH's FEI number is 3008320803.

What types of violations has Caesar und Loretz GmbH received?

Caesar und Loretz GmbH has been cited for 2 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 Caesar und Loretz GmbH come from?

All FDA import refusal data for Caesar und Loretz 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.