Merck, Inc.
⚠️ High Risk
FEI: 2210048 • Kenilworth, NJ • UNITED STATES
FEI Number
2210048
Location
Kenilworth, NJ
Country
UNITED STATESAddress
2000 Galloping Hill Rd, , Kenilworth, NJ, United States
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 4/11/2025 | 62LCY47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | Division of Northern Border Imports (DNBI) | |
| 3/22/2023 | 61EDQ01CROMOLYN SODIUM (ANTI-ASTHMATIC) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/10/2022 | 64RCL21SOMATROPIN (HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2022 | 60ZDB15IVERMECTIN AND COMBINATIONS (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/29/2021 | 64UCY06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/19/2021 | 61PDY68SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2020 | 61PCA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2020 | 62ODA18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/5/2020 | 61PCA68SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/18/2020 | 61JDA15EZETIMIBE | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/12/2020 | 60LDL01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/12/2020 | 61WDJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/23/2018 | 61PDY26METFORMIN (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 4/1/2016 | 64GDY07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/15/2015 | 61TDA12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/26/2015 | 57CL99VIRAL VACCINES, N.E.C. | 71NO LICENSE | Division of Northeast Imports (DNEI) |
| 8/5/2014 | 61PBY99ANTI-DIABETIC N.E.C. | Division of Northeast Imports (DNEI) | |
| 7/5/2013 | 63BCQ25FLUTICASONE PROPIONATE (BRONCHODILATOR) | New Orleans District Office (NOL-DO) | |
| 8/21/2009 | 63BBZ32FORMOTEROL FUMARATE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 1/31/2007 | 63EIY33EPTIFIBATIDE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 1/31/2007 | 61JIY14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/24/2005 | 64LAY06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/15/2002 | 61NDA99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Merck, Inc.'s FDA import refusal history?
Merck, Inc. (FEI: 2210048) has 23 FDA import refusal record(s) in our database, spanning from 8/15/2002 to 4/11/2025.
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, Inc.'s FEI number is 2210048.
What types of violations has Merck, Inc. received?
Merck, Inc. 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, Inc. come from?
All FDA import refusal data for Merck, Inc. 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.