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NOVATECH TIBBI CIHAZ URUNLERI SA

⚠️ Moderate Risk

FEI: 3021369458 • Gaziantep • TOKELAU

FEI

FEI Number

3021369458

📍

Location

Gaziantep

🇹🇰

Country

TOKELAU
🏢

Address

2. Organiza Sanayi Bolg, , Gaziantep, , Tokelau

Moderate Risk

FDA Import Risk Assessment

36.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/11/2022
Latest Refusal
2/11/2022
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
21.7×20%
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
2/11/2022
83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is NOVATECH TIBBI CIHAZ URUNLERI SA's FDA import refusal history?

NOVATECH TIBBI CIHAZ URUNLERI SA (FEI: 3021369458) has 1 FDA import refusal record(s) in our database, spanning from 2/11/2022 to 2/11/2022.

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. NOVATECH TIBBI CIHAZ URUNLERI SA's FEI number is 3021369458.

What types of violations has NOVATECH TIBBI CIHAZ URUNLERI SA received?

NOVATECH TIBBI CIHAZ URUNLERI SA 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 NOVATECH TIBBI CIHAZ URUNLERI SA come from?

All FDA import refusal data for NOVATECH TIBBI CIHAZ URUNLERI SA 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.