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RTA LAB BIY URUNLER ILAC VE MAKI

⚠️ Moderate Risk

FEI: 3016852206 • Gebze, Kocaeli • TURKEY

FEI

FEI Number

3016852206

📍

Location

Gebze, Kocaeli

🇹🇷

Country

TURKEY
🏢

Address

Hacihalil Mah., Cumhuriyet Cad. No 3, Gebze, Kocaeli, Turkey

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
6/26/2020
Latest Refusal
6/26/2020
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
6/26/2020
83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
508NO 510(K)
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is RTA LAB BIY URUNLER ILAC VE MAKI's FDA import refusal history?

RTA LAB BIY URUNLER ILAC VE MAKI (FEI: 3016852206) has 1 FDA import refusal record(s) in our database, spanning from 6/26/2020 to 6/26/2020.

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. RTA LAB BIY URUNLER ILAC VE MAKI's FEI number is 3016852206.

What types of violations has RTA LAB BIY URUNLER ILAC VE MAKI received?

RTA LAB BIY URUNLER ILAC VE MAKI 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 RTA LAB BIY URUNLER ILAC VE MAKI come from?

All FDA import refusal data for RTA LAB BIY URUNLER ILAC VE MAKI 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.