Versele-Laga nv
⚠️ Moderate Risk
FEI: 1000354526 • Deinze, East Flanders • BELGIUM
FEI Number
1000354526
Location
Deinze, East Flanders
Country
BELGIUMAddress
Kapellestraat 70, , Deinze, East Flanders, Belgium
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/18/2013 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 10/14/2009 | 54AMZ99VITAMIN, N.E.C. | 11UNSAFE COL | Florida District Office (FLA-DO) |
| 5/11/2006 | 65CRA99NUTRIENT/TONIC N.E.C. | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
| 9/21/2005 | 68YBA99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | New England District Office (NWE-DO) | |
| 9/21/2005 | 68YBA99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | New England District Office (NWE-DO) | |
| 8/23/2004 | 56BYE03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 8/23/2004 | 66VPY99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 8/23/2004 | 66VPY99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 8/23/2004 | 66VPY99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 8/23/2004 | 66VPY99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 8/23/2004 | 66VPY99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 8/23/2004 | 66VPY99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 8/23/2004 | 66VKY99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Versele-Laga nv's FDA import refusal history?
Versele-Laga nv (FEI: 1000354526) has 13 FDA import refusal record(s) in our database, spanning from 8/23/2004 to 9/18/2013.
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. Versele-Laga nv's FEI number is 1000354526.
What types of violations has Versele-Laga nv received?
Versele-Laga nv has been cited for 5 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 Versele-Laga nv come from?
All FDA import refusal data for Versele-Laga nv 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.