Ceva Sante Animale
⚠️ Moderate Risk
FEI: 3003222551 • Libourne Cedex, Gironde • FRANCE
FEI Number
3003222551
Location
Libourne Cedex, Gironde
Country
FRANCEAddress
Ceva Sante Animale, Sanofi; Zi; 10 Avenue De La Ballastiere; Cs 30126, Libourne Cedex, Gironde, 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/14/2013 | 63AQR10TILUDRONATE DISODIUM (BONE CALCIUM REGULATOR) | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 6/1/2012 | 63ALZ10TILUDRONATE DISODIUM (BONE CALCIUM REGULATOR) | New Orleans District Office (NOL-DO) | |
| 6/15/2011 | 62GQX99ANTI-INFLAMMATORY N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 6/8/2009 | 62GLR99ANTI-INFLAMMATORY N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 6/21/2007 | 68YYY02HORSES ANIMAL DRUGS N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 9/20/2006 | 62GQA88CARPROFEN (ANTI-INFLAMMATORY) | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 6/21/2004 | 68FYY20HORMONES USED MORE THAN 1 SPECIES | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Ceva Sante Animale's FDA import refusal history?
Ceva Sante Animale (FEI: 3003222551) has 7 FDA import refusal record(s) in our database, spanning from 6/21/2004 to 2/14/2013.
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. Ceva Sante Animale's FEI number is 3003222551.
What types of violations has Ceva Sante Animale received?
Ceva Sante Animale 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 Ceva Sante Animale come from?
All FDA import refusal data for Ceva Sante Animale 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.