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BILIM ILAC SANAYII VE TICARET

⚠️ High Risk

FEI: 3016943100 • Gebze • TURKEY

FEI

FEI Number

3016943100

📍

Location

Gebze

🇹🇷

Country

TURKEY
🏢

Address

Gebze Organize Sanayi B, , Gebze, , Turkey

High Risk

FDA Import Risk Assessment

51.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
9/19/2023
Latest Refusal
9/19/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
53.2×20%
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
9/19/2023
60SCB26SUCRALFATE (ANTACID)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BILIM ILAC SANAYII VE TICARET's FDA import refusal history?

BILIM ILAC SANAYII VE TICARET (FEI: 3016943100) has 1 FDA import refusal record(s) in our database, spanning from 9/19/2023 to 9/19/2023.

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. BILIM ILAC SANAYII VE TICARET's FEI number is 3016943100.

What types of violations has BILIM ILAC SANAYII VE TICARET received?

BILIM ILAC SANAYII VE TICARET 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 BILIM ILAC SANAYII VE TICARET come from?

All FDA import refusal data for BILIM ILAC SANAYII VE TICARET 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.