Merck Sharp & Dohme LLC
⚠️ Moderate Risk
FEI: 2510592 • West Point, PA • UNITED STATES
FEI Number
2510592
Location
West Point, PA
Country
UNITED STATESAddress
770 Sumneytown Pike, , West Point, PA, United States
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 9/5/2014 | 62IIP99ANTI-NEOPLASTIC N.E.C. | 27DRUG GMPS | Baltimore District Office (BLT-DO) |
| 11/14/2012 | 57HH42PNEUMOCOCCAL VACCINE | 71NO LICENSE | New York District Office (NYK-DO) |
| 6/10/2010 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/21/2003 | 61JCA99ANTI-CHOLESTEREMIC, N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 5/10/2002 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 5/10/2002 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Merck Sharp & Dohme LLC's FDA import refusal history?
Merck Sharp & Dohme LLC (FEI: 2510592) has 7 FDA import refusal record(s) in our database, spanning from 5/10/2002 to 3/24/2016.
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 LLC's FEI number is 2510592.
What types of violations has Merck Sharp & Dohme LLC received?
Merck Sharp & Dohme LLC has been cited for 4 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 LLC come from?
All FDA import refusal data for Merck Sharp & Dohme LLC 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.