Les Laboratoires Servier Industrie
⚠️ Moderate Risk
FEI: 3007216124 • Gidy, Loiret • FRANCE
FEI Number
3007216124
Location
Gidy, Loiret
Country
FRANCEAddress
22 Rue Garnier, , Gidy, Loiret, France
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).
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 |
|---|---|---|---|
| 2/13/2015 | 64BCB48INDAPAMIDE (DIURETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/12/2011 | 61NCA99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2011 | 64BCB48INDAPAMIDE (DIURETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/17/2005 | 61PDA99ANTI-DIABETIC N.E.C. | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 3/21/2005 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/14/2004 | 65VBC99SEDATIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Les Laboratoires Servier Industrie's FDA import refusal history?
Les Laboratoires Servier Industrie (FEI: 3007216124) has 6 FDA import refusal record(s) in our database, spanning from 12/14/2004 to 2/13/2015.
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 Laboratoires Servier Industrie's FEI number is 3007216124.
What types of violations has Les Laboratoires Servier Industrie received?
Les Laboratoires Servier Industrie has been cited for 2 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 Laboratoires Servier Industrie come from?
All FDA import refusal data for Les Laboratoires 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.