MERCH SHARP & DOHME CORP
⚠️ Moderate Risk
FEI: 3014294216 • Northumberland • UNITED KINGDOM
FEI Number
3014294216
Location
Northumberland
Country
UNITED KINGDOMAddress
Shotton Lane Camlingto, , Northumberland, , 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 |
|---|---|---|---|
| 6/30/2021 | 61PCY68SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/3/2019 | 61PCA68SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2018 | 61PDY68SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MERCH SHARP & DOHME CORP's FDA import refusal history?
MERCH SHARP & DOHME CORP (FEI: 3014294216) has 3 FDA import refusal record(s) in our database, spanning from 5/10/2018 to 6/30/2021.
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. MERCH SHARP & DOHME CORP's FEI number is 3014294216.
What types of violations has MERCH SHARP & DOHME CORP received?
MERCH SHARP & DOHME CORP 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 MERCH SHARP & DOHME CORP come from?
All FDA import refusal data for MERCH SHARP & DOHME CORP 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.