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ENJOY YOUR BUSINESS ENJOY YOUR LIFE

⚠️ Moderate Risk

FEI: 3017347237 • Welzheim, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3017347237

📍

Location

Welzheim, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Kirchplatz 9, , Welzheim, Baden-Wurttemberg, 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
11/10/2020
Latest Refusal
11/10/2020
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

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
11/10/2020
83QKOREAGENT, CORONAVIRUS SEROLOGICAL
508NO 510(K)
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is ENJOY YOUR BUSINESS ENJOY YOUR LIFE's FDA import refusal history?

ENJOY YOUR BUSINESS ENJOY YOUR LIFE (FEI: 3017347237) has 1 FDA import refusal record(s) in our database, spanning from 11/10/2020 to 11/10/2020.

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. ENJOY YOUR BUSINESS ENJOY YOUR LIFE's FEI number is 3017347237.

What types of violations has ENJOY YOUR BUSINESS ENJOY YOUR LIFE received?

ENJOY YOUR BUSINESS ENJOY YOUR LIFE 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 ENJOY YOUR BUSINESS ENJOY YOUR LIFE come from?

All FDA import refusal data for ENJOY YOUR BUSINESS ENJOY YOUR LIFE 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.