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Abbott Laboratuarlari Ithalat ve Ihracat Ticaret A.S.

⚠️ Moderate Risk

FEI: 3005134248 • Beykoz-Istanbul • TURKEY

FEI

FEI Number

3005134248

📍

Location

Beykoz-Istanbul

🇹🇷

Country

TURKEY
🏢

Address

Ekinciler Cad. Hedef Plaza Kat: 6, Kavac, , Beykoz-Istanbul, , Turkey

Moderate Risk

FDA Import Risk Assessment

28.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/20/2024
Latest Refusal
2/20/2024
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
61.7×20%
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).

Refusal History

DateProductViolationsDivision
2/20/2024
64ECA03PANCRELIPASE (ENZYME)
472NO ENGLISH
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Abbott Laboratuarlari Ithalat ve Ihracat Ticaret A.S.'s FDA import refusal history?

Abbott Laboratuarlari Ithalat ve Ihracat Ticaret A.S. (FEI: 3005134248) has 1 FDA import refusal record(s) in our database, spanning from 2/20/2024 to 2/20/2024.

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. Abbott Laboratuarlari Ithalat ve Ihracat Ticaret A.S.'s FEI number is 3005134248.

What types of violations has Abbott Laboratuarlari Ithalat ve Ihracat Ticaret A.S. received?

Abbott Laboratuarlari Ithalat ve Ihracat Ticaret 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 Abbott Laboratuarlari Ithalat ve Ihracat Ticaret A.S. come from?

All FDA import refusal data for Abbott Laboratuarlari Ithalat ve Ihracat 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.