Merck Sharp & Dohme LLC
⚠️ Moderate Risk
FEI: 1112271 • Elkton, VA • UNITED STATES
FEI Number
1112271
Location
Elkton, VA
Country
UNITED STATESAddress
2778 South East Side Hwy, , Elkton, VA, 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).
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).
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.
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/24/2014 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 10/10/2014 | 56YCS99ANTIBIOTIC N.E.C. | Baltimore District Office (BLT-DO) | |
| 10/10/2014 | 56YCS99ANTIBIOTIC N.E.C. | Baltimore District Office (BLT-DO) | |
| 10/10/2014 | 56YCS99ANTIBIOTIC N.E.C. | Baltimore District Office (BLT-DO) | |
| 5/11/2004 | 61FCS19CEFOXITIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 331DR QUALITC | Baltimore District Office (BLT-DO) |
| 5/11/2004 | 64UDS04CILASTATIN SODIUM/IMIPENEM (INHIBITOR (DECARBOXYLASE)) | 331DR QUALITC | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Merck Sharp & Dohme LLC's FDA import refusal history?
Merck Sharp & Dohme LLC (FEI: 1112271) has 7 FDA import refusal record(s) in our database, spanning from 5/11/2004 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 1112271.
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.