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MSD International GmbH (Singapore Branch)

⚠️ Moderate Risk

FEI: 3004199021 • Singapore • SINGAPORE

FEI

FEI Number

3004199021

📍

Location

Singapore

🇸🇬

Country

SINGAPORE
🏢

Address

70 Tuas West Drive, , Singapore, , Singapore

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
11/24/2014
Latest Refusal
11/24/2014
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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
11/24/2014
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
11/24/2014
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
11/24/2014
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is MSD International GmbH (Singapore Branch)'s FDA import refusal history?

MSD International GmbH (Singapore Branch) (FEI: 3004199021) has 3 FDA import refusal record(s) in our database, spanning from 11/24/2014 to 11/24/2014.

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. MSD International GmbH (Singapore Branch)'s FEI number is 3004199021.

What types of violations has MSD International GmbH (Singapore Branch) received?

MSD International GmbH (Singapore Branch) 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 MSD International GmbH (Singapore Branch) come from?

All FDA import refusal data for MSD International GmbH (Singapore Branch) 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.