Les Laboratories Servier Industrie
⚠️ High Risk
FEI: 3004055168 • Gidy, Loiret • FRANCE
FEI Number
3004055168
Location
Gidy, Loiret
Country
FRANCEAddress
905 route de Saran, , Gidy, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2025 | 61NDA99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2025 | 63EDA35IVABRADINE (CARDIAC DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2021 | 61NDA99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2021 | 61DCA99ANTI-ANGINAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/24/2020 | 62ODA03PERINDOPRIL ERBUMINE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/8/2016 | 64BCA48INDAPAMIDE (DIURETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/25/2016 | 61KDA38PENTHIENATE BROMIDE (ANTI-CHOLINERGIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/2/2016 | 64BCC48INDAPAMIDE (DIURETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/4/2015 | 64UCB99INHIBITOR N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/13/2011 | 61PCB99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2009 | 66VDB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2009 | 62OCB03PERINDOPRIL ERBUMINE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/3/2008 | 61PCF99ANTI-DIABETIC N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/10/2008 | 61PCB31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/9/2008 | 64BCP48INDAPAMIDE (DIURETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/27/2008 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/6/2006 | 61PCP99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/1/2006 | 62OCP03PERINDOPRIL ERBUMINE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/18/2005 | 62CCC99ANTI-HYPERTENSIVE N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/18/2005 | 61PDB99ANTI-DIABETIC N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 7/22/2005 | 63FCA99CARDIOTONIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/13/2005 | 63FDY99CARDIOTONIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/4/2005 | 62CDY99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2003 | 61PDB99ANTI-DIABETIC N.E.C. | 342PERSONALRX | Seattle District Office (SEA-DO) |
| 9/10/2002 | 63XAY99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Les Laboratories Servier Industrie's FDA import refusal history?
Les Laboratories Servier Industrie (FEI: 3004055168) has 26 FDA import refusal record(s) in our database, spanning from 9/10/2002 to 9/24/2025.
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. Les Laboratories Servier Industrie's FEI number is 3004055168.
What types of violations has Les Laboratories Servier Industrie received?
Les Laboratories Servier Industrie 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 Les Laboratories Servier Industrie come from?
All FDA import refusal data for Les Laboratories Servier Industrie 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.