MERCK SHARP & DOHME LTD
⚠️ Moderate Risk
FEI: 3012317452 • Hoddesdon • UNITED KINGDOM
FEI Number
3012317452
Location
Hoddesdon
Country
UNITED KINGDOMAddress
Hertford Road, , Hoddesdon, , United Kingdom
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 |
|---|---|---|---|
| 4/16/2021 | 63BDQ01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/16/2021 | 61EDY09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/20/2019 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/6/2018 | 64UCB06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/7/2017 | 61XCL99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/1/2016 | 60KCA15TIBOLONE (ANABOLIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is MERCK SHARP & DOHME LTD's FDA import refusal history?
MERCK SHARP & DOHME LTD (FEI: 3012317452) has 6 FDA import refusal record(s) in our database, spanning from 9/1/2016 to 4/16/2021.
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 LTD's FEI number is 3012317452.
What types of violations has MERCK SHARP & DOHME LTD received?
MERCK SHARP & DOHME LTD 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 LTD come from?
All FDA import refusal data for MERCK SHARP & DOHME LTD 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.