MSD International GmbH (Singapore Branch)
⚠️ Moderate Risk
FEI: 3003431146 • Singapore • SINGAPORE
FEI Number
3003431146
Location
Singapore
Country
SINGAPOREAddress
21 Tuas South Avenue 6, , Singapore, , Singapore
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/22/2018 | 62VCA61RALTEGRAVIR POTASSIUM (ANTI-VIRAL) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 3/24/2016 | 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) |
| 2/12/2009 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/12/2008 | 61JIA99ANTI-CHOLESTEREMIC, N.E.C. | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 6/19/2004 | 61JIA99ANTI-CHOLESTEREMIC, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is MSD International GmbH (Singapore Branch)'s FDA import refusal history?
MSD International GmbH (Singapore Branch) (FEI: 3003431146) has 7 FDA import refusal record(s) in our database, spanning from 6/19/2004 to 6/22/2018.
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. MSD International GmbH (Singapore Branch)'s FEI number is 3003431146.
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.