ImportRefusal LogoImportRefusal

ACDC KOZMETIK SANAYI VE TICARET A.S.

⚠️ Moderate Risk

FEI: 3014535859 • Akdeniz, TR-45 • TURKEY

FEI

FEI Number

3014535859

📍

Location

Akdeniz, TR-45

🇹🇷

Country

TURKEY
🏢

Address

Hal Mah Turgut Ozal Bulvan, Yeni Hal Kompleksi No:24 U Blok 6, Akdeniz, TR-45, Turkey

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/4/2019
Latest Refusal
3/4/2019
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

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
3/4/2019
65PCY02SILDENAFIL CITRATE (REGULATOR)
16DIRECTIONS
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is ACDC KOZMETIK SANAYI VE TICARET A.S.'s FDA import refusal history?

ACDC KOZMETIK SANAYI VE TICARET A.S. (FEI: 3014535859) has 1 FDA import refusal record(s) in our database, spanning from 3/4/2019 to 3/4/2019.

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. ACDC KOZMETIK SANAYI VE TICARET A.S.'s FEI number is 3014535859.

What types of violations has ACDC KOZMETIK SANAYI VE TICARET A.S. received?

ACDC KOZMETIK SANAYI VE TICARET A.S. 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 ACDC KOZMETIK SANAYI VE TICARET A.S. come from?

All FDA import refusal data for ACDC KOZMETIK SANAYI VE TICARET A.S. 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.