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Inan Optik San Ve Tic A.S.

⚠️ Moderate Risk

FEI: 3004730438 • Istanbul • TURKEY

FEI

FEI Number

3004730438

📍

Location

Istanbul

🇹🇷

Country

TURKEY
🏢

Address

No 48 Kat 3 Sirkeci, , Istanbul, , Turkey

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/26/2004
Latest Refusal
10/26/2004
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
10/26/2004
56YCC99ANTIBIOTIC N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Inan Optik San Ve Tic A.S.'s FDA import refusal history?

Inan Optik San Ve Tic A.S. (FEI: 3004730438) has 1 FDA import refusal record(s) in our database, spanning from 10/26/2004 to 10/26/2004.

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. Inan Optik San Ve Tic A.S.'s FEI number is 3004730438.

What types of violations has Inan Optik San Ve Tic A.S. received?

Inan Optik San Ve Tic A.S. 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 Inan Optik San Ve Tic A.S. come from?

All FDA import refusal data for Inan Optik San Ve Tic 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.