Merck Sante s.a.s
⚠️ High Risk
FEI: 3002807504 • Semoy, Loiret • FRANCE
FEI Number
3002807504
Location
Semoy, Loiret
Country
FRANCEAddress
2 rue du Pressoir Vert, , Semoy, Loiret, France
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/4/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/27/2024 | 61PDA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/21/2016 | 61PCY55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/11/2016 | 66JDY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 2/1/2016 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/11/2013 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/3/2008 | 61PCB55METFORMIN HCL (ANTI-DIABETIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/27/2007 | 61PCY99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/27/2005 | 61PDB26METFORMIN (ANTI-DIABETIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Merck Sante s.a.s's FDA import refusal history?
Merck Sante s.a.s (FEI: 3002807504) has 10 FDA import refusal record(s) in our database, spanning from 5/3/2005 to 3/4/2025.
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 Sante s.a.s's FEI number is 3002807504.
What types of violations has Merck Sante s.a.s received?
Merck Sante s.a.s 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 Sante s.a.s come from?
All FDA import refusal data for Merck Sante s.a.s 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.