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WORLD MEDICINE ILAQ

⚠️ Moderate Risk

FEI: 3013486385 • Istanbul • TURKEY

FEI

FEI Number

3013486385

📍

Location

Istanbul

🇹🇷

Country

TURKEY
🏢

Address

Evren Mah. Cami Yolu Cad No 50 Pk 34212, , Istanbul, , Turkey

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/2/2017
Latest Refusal
6/2/2017
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
6/2/2017
65CCY07LEVOCARNITINE (NUTRIENT/TONIC)
472NO ENGLISH
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is WORLD MEDICINE ILAQ's FDA import refusal history?

WORLD MEDICINE ILAQ (FEI: 3013486385) has 1 FDA import refusal record(s) in our database, spanning from 6/2/2017 to 6/2/2017.

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. WORLD MEDICINE ILAQ's FEI number is 3013486385.

What types of violations has WORLD MEDICINE ILAQ received?

WORLD MEDICINE ILAQ 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 WORLD MEDICINE ILAQ come from?

All FDA import refusal data for WORLD MEDICINE ILAQ 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.