Merck Sharp & Dohme BV
⚠️ High Risk
FEI: 3002807658 • Haarlem, Noord-Holland • NETHERLANDS
FEI Number
3002807658
Location
Haarlem, Noord-Holland
Country
NETHERLANDSAddress
Waarderweg 39, , Haarlem, Noord-Holland, Netherlands
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/3/2023 | 62LCA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2023 | 62OCE41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 57CH29VARICELLA VIRUS VACCINE | Division of Southeast Imports (DSEI) | |
| 3/30/2018 | 65JCA31PROGESTERONE (PROGESTIN) | Division of Northern Border Imports (DNBI) | |
| 3/30/2018 | 64MCY04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | Division of Northern Border Imports (DNBI) | |
| 4/17/2017 | 64MCP11GANIRELIX ACETATE (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/11/2016 | 63ABY02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 4/20/2012 | 60LDB87RIZATRIPTAN BENZOATE (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/26/2007 | 60LCE99ANALGESIC, N.E.C. | New Orleans District Office (NOL-DO) | |
| 7/26/2007 | 60LCE99ANALGESIC, N.E.C. | New Orleans District Office (NOL-DO) | |
| 7/26/2007 | 60LCE99ANALGESIC, N.E.C. | New Orleans District Office (NOL-DO) | |
| 7/26/2007 | 60LCE99ANALGESIC, N.E.C. | New Orleans District Office (NOL-DO) | |
| 7/26/2007 | 62CCB38METHYLDOPA (ANTI-HYPERTENSIVE) | New Orleans District Office (NOL-DO) | |
| 7/26/2007 | 62CCB38METHYLDOPA (ANTI-HYPERTENSIVE) | New Orleans District Office (NOL-DO) | |
| 7/26/2007 | 60LCM99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/6/2006 | 62GDB49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/19/2004 | 61JCA14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/13/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Merck Sharp & Dohme BV's FDA import refusal history?
Merck Sharp & Dohme BV (FEI: 3002807658) has 18 FDA import refusal record(s) in our database, spanning from 4/13/2004 to 10/3/2023.
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 BV's FEI number is 3002807658.
What types of violations has Merck Sharp & Dohme BV received?
Merck Sharp & Dohme BV has been cited for 6 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 BV come from?
All FDA import refusal data for Merck Sharp & Dohme BV 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.