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TOSAMA D.D.

⚠️ Moderate Risk

FEI: 3007740671 • Domzale, Domzale • SLOVENIA

FEI

FEI Number

3007740671

📍

Location

Domzale, Domzale

🇸🇮

Country

SLOVENIA
🏢

Address

Saranoviceva Cesta 35, , Domzale, Domzale, Slovenia

Moderate Risk

FDA Import Risk Assessment

31.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
10/19/2023
Latest Refusal
10/19/2023
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
17.7×30%
Recency
41.5×20%
Frequency
20.0×10%
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

1182×

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).

3412×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
10/19/2023
80OKFBODY FLUID DISPOSAL KIT
118NOT LISTED
341REGISTERED
Division of Northern Border Imports (DNBI)
10/19/2023
80FQMBANDAGE, ELASTIC
118NOT LISTED
341REGISTERED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is TOSAMA D.D.'s FDA import refusal history?

TOSAMA D.D. (FEI: 3007740671) has 2 FDA import refusal record(s) in our database, spanning from 10/19/2023 to 10/19/2023.

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. TOSAMA D.D.'s FEI number is 3007740671.

What types of violations has TOSAMA D.D. received?

TOSAMA D.D. 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 TOSAMA D.D. come from?

All FDA import refusal data for TOSAMA D.D. 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.