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MERCK SDN

⚠️ Moderate Risk

FEI: 3014530209 • Selangor • MALAYSIA

FEI

FEI Number

3014530209

📍

Location

Selangor

🇲🇾

Country

MALAYSIA
🏢

Address

Menara Sunway Annexe Ja, , Selangor, , Malaysia

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
7/31/2018
Latest Refusal
7/31/2018
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
7/31/2018
56DCJ20GENTAMICIN (AMINOGLYCOSIDES)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is MERCK SDN's FDA import refusal history?

MERCK SDN (FEI: 3014530209) has 1 FDA import refusal record(s) in our database, spanning from 7/31/2018 to 7/31/2018.

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 SDN's FEI number is 3014530209.

What types of violations has MERCK SDN received?

MERCK SDN 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 SDN come from?

All FDA import refusal data for MERCK SDN 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.