ImportRefusal LogoImportRefusal

MERCK SHARP DOHME ILA LAR LTD. STI.

⚠️ Moderate Risk

FEI: 3014783552 • Istanbul • TURKEY

FEI

FEI Number

3014783552

📍

Location

Istanbul

🇹🇷

Country

TURKEY
🏢

Address

Esentepe Mahallesi B Ykdere Caddesi, No:199 Levent199 Ofis Blogu Kat13, Istanbul, , Turkey

Moderate Risk

FDA Import Risk Assessment

40.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/10/2021
Latest Refusal
11/10/2021
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
2.6×20%
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
11/10/2021
64MCL10UROFOLLITROPIN (GONAD-STIMULATING PRINCIPLE)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is MERCK SHARP DOHME ILA LAR LTD. STI.'s FDA import refusal history?

MERCK SHARP DOHME ILA LAR LTD. STI. (FEI: 3014783552) has 1 FDA import refusal record(s) in our database, spanning from 11/10/2021 to 11/10/2021.

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. MERCK SHARP DOHME ILA LAR LTD. STI.'s FEI number is 3014783552.

What types of violations has MERCK SHARP DOHME ILA LAR LTD. STI. received?

MERCK SHARP DOHME ILA LAR LTD. STI. 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 MERCK SHARP DOHME ILA LAR LTD. STI. come from?

All FDA import refusal data for MERCK SHARP DOHME ILA LAR LTD. STI. 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.