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GENBODY INC MT PROMEDT CONSULTIN

⚠️ Moderate Risk

FEI: 3021741635 • St. Ingbert, Saarland • GERMANY

FEI

FEI Number

3021741635

📍

Location

St. Ingbert, Saarland

🇩🇪

Country

GERMANY
🏢

Address

Altenhofstr. # 80, , St. Ingbert, Saarland, Germany

Moderate Risk

FDA Import Risk Assessment

34.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/7/2022
Latest Refusal
4/7/2022
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
10.7×20%
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
4/7/2022
83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GENBODY INC MT PROMEDT CONSULTIN's FDA import refusal history?

GENBODY INC MT PROMEDT CONSULTIN (FEI: 3021741635) has 1 FDA import refusal record(s) in our database, spanning from 4/7/2022 to 4/7/2022.

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. GENBODY INC MT PROMEDT CONSULTIN's FEI number is 3021741635.

What types of violations has GENBODY INC MT PROMEDT CONSULTIN received?

GENBODY INC MT PROMEDT CONSULTIN 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 GENBODY INC MT PROMEDT CONSULTIN come from?

All FDA import refusal data for GENBODY INC MT PROMEDT CONSULTIN 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.