Excel Vision
⚠️ Moderate Risk
FEI: 3007058211 • Annonay, Ardeche • FRANCE
FEI Number
3007058211
Location
Annonay, Ardeche
Country
FRANCEAddress
Zone Industrielle, 27 Rue De La Lombardiere, Annonay, Ardeche, 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.
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.
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 |
|---|---|---|---|
| 5/11/2015 | 68YAK99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | New York District Office (NYK-DO) |
| 5/11/2015 | 68XYY10SMALL ANIMAL DEVICE/DIAG PROD FOR ANIMAL | 72NEW VET DR | New York District Office (NYK-DO) |
| 5/11/2015 | 68XYY10SMALL ANIMAL DEVICE/DIAG PROD FOR ANIMAL | 72NEW VET DR | New York District Office (NYK-DO) |
| 3/13/2008 | 66VAK99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Excel Vision's FDA import refusal history?
Excel Vision (FEI: 3007058211) has 4 FDA import refusal record(s) in our database, spanning from 3/13/2008 to 5/11/2015.
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. Excel Vision's FEI number is 3007058211.
What types of violations has Excel Vision received?
Excel Vision 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 Excel Vision come from?
All FDA import refusal data for Excel Vision 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.