Merck, Sharp & Dohme
⚠️ High Risk
FEI: 3002807611 • Hoddesdon, Hertfordshire • UNITED KINGDOM
FEI Number
3002807611
Location
Hoddesdon, Hertfordshire
Country
UNITED KINGDOMAddress
West Hill, Hertford Road, Hoddesdon, Hertfordshire, United Kingdom
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2024 | 61PCA68SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/27/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/11/2015 | 61SBJ99ANTI-ECZEMATIC N.E.C. | Cincinnati District Office (CIN-DO) | |
| 12/28/2011 | 61ECA09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2009 | 64GAB20FENESTREL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/26/2008 | 66VIA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 8/26/2008 | 66VIA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 4/5/2007 | 62OIY28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | New Orleans District Office (NOL-DO) | |
| 7/14/2006 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2006 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2006 | 61ECK01CROMOLYN SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/18/2006 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/18/2006 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/18/2006 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/7/2005 | 61XCA14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/23/2005 | 63ACY02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/7/2002 | 61XAW14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Merck, Sharp & Dohme's FDA import refusal history?
Merck, Sharp & Dohme (FEI: 3002807611) has 22 FDA import refusal record(s) in our database, spanning from 10/7/2002 to 6/13/2024.
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's FEI number is 3002807611.
What types of violations has Merck, Sharp & Dohme received?
Merck, Sharp & Dohme has been cited for 3 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 come from?
All FDA import refusal data for Merck, Sharp & Dohme 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.