Merial
⚠️ High Risk
FEI: 3002948269 • Lyon, Rhone • FRANCE
FEI Number
3002948269
Location
Lyon, Rhone
Country
FRANCEAddress
29 avenue Tony Garnier, , Lyon, Rhone, 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
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.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 8/31/2018 | 66VRK99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 3/1/2017 | 68YCA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/21/2017 | 68YCA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/21/2017 | 66VOA99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/21/2017 | 66VOA99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/15/2017 | 68YYA99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/14/2017 | 68YAA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/13/2017 | 68YAA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/9/2017 | 68YAA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/9/2017 | 68YBA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/9/2017 | 68YAA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/9/2017 | 66VQA99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 1/24/2017 | 62LPA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/17/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 8/17/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 8/17/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 8/17/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 8/17/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 8/17/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 8/17/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 8/17/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 7/18/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/18/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/18/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/18/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/18/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 6/8/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 6/8/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 6/8/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 6/3/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 6/3/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 3/23/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 3/23/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 3/23/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 3/23/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 3/23/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 3/23/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 3/23/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 3/23/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 3/23/2016 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/20/2015 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/20/2015 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/20/2015 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/20/2015 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/20/2015 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/20/2015 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/20/2015 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/20/2015 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 6/2/2015 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 1/26/2015 | 68YDL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 1/31/2013 | 68YDN02HORSES ANIMAL DRUGS N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 1/31/2013 | 68YDP02HORSES ANIMAL DRUGS N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 2/8/2010 | 68YIL10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | New York District Office (NYK-DO) |
| 10/2/2008 | 68YIS99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 10/5/2001 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 118NOT LISTED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Merial's FDA import refusal history?
Merial (FEI: 3002948269) has 55 FDA import refusal record(s) in our database, spanning from 10/5/2001 to 8/31/2018.
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. Merial's FEI number is 3002948269.
What types of violations has Merial received?
Merial 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 Merial come from?
All FDA import refusal data for Merial 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.