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NOMA YAPI DIS TICARET VE SANAY

Low Risk

FEI: 3015290640 • Istanbul • TURKEY

FEI

FEI Number

3015290640

📍

Location

Istanbul

🇹🇷

Country

TURKEY
🏢

Address

Oruc Reis Mahallesi Tek, , Istanbul, , Turkey

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
1/28/2020
Latest Refusal
1/28/2020
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
1/28/2020
79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
118NOT LISTED
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is NOMA YAPI DIS TICARET VE SANAY's FDA import refusal history?

NOMA YAPI DIS TICARET VE SANAY (FEI: 3015290640) has 1 FDA import refusal record(s) in our database, spanning from 1/28/2020 to 1/28/2020.

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. NOMA YAPI DIS TICARET VE SANAY's FEI number is 3015290640.

What types of violations has NOMA YAPI DIS TICARET VE SANAY received?

NOMA YAPI DIS TICARET VE SANAY 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 NOMA YAPI DIS TICARET VE SANAY come from?

All FDA import refusal data for NOMA YAPI DIS TICARET VE SANAY 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.