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VITROSENS BIYOTEKNOLOJI LTI

⚠️ Moderate Risk

FEI: 3021435584 • Istanbul, Istanbul • TURKEY

FEI

FEI Number

3021435584

📍

Location

Istanbul, Istanbul

🇹🇷

Country

TURKEY
🏢

Address

Serifali Mah Sehit Sk No 17 Ic Kapi, No 1, Istanbul, Istanbul, Turkey

Moderate Risk

FDA Import Risk Assessment

34.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/3/2022
Latest Refusal
3/3/2022
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
8.8×20%
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
3/3/2022
83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES
508NO 510(K)
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is VITROSENS BIYOTEKNOLOJI LTI's FDA import refusal history?

VITROSENS BIYOTEKNOLOJI LTI (FEI: 3021435584) has 1 FDA import refusal record(s) in our database, spanning from 3/3/2022 to 3/3/2022.

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. VITROSENS BIYOTEKNOLOJI LTI's FEI number is 3021435584.

What types of violations has VITROSENS BIYOTEKNOLOJI LTI received?

VITROSENS BIYOTEKNOLOJI LTI 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 VITROSENS BIYOTEKNOLOJI LTI come from?

All FDA import refusal data for VITROSENS BIYOTEKNOLOJI LTI 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.