Apotheek Jorissen Nv
⚠️ Moderate Risk
FEI: 3000939205 • Hoeselt, Limburg • BELGIUM
FEI Number
3000939205
Location
Hoeselt, Limburg
Country
BELGIUMAddress
Tongersesteenweg 47b, , Hoeselt, Limburg, 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.
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).
VET LEGEND
The article appears to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/6/2006 | 62LRA99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C. | New Orleans District Office (NOL-DO) | |
| 1/6/2006 | 62LQY01CARNIDAZOLE (ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL) | 343VET LEGEND | New Orleans District Office (NOL-DO) |
| 1/6/2006 | 68YYY99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | New Orleans District Office (NOL-DO) | |
| 9/15/2005 | 56LXL99NON-CERT VET ANTIBIOTIC, N.E.C. | New York District Office (NYK-DO) | |
| 9/15/2005 | 56BXB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | New York District Office (NYK-DO) | |
| 8/12/2005 | 62LOA01CARNIDAZOLE (ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Apotheek Jorissen Nv's FDA import refusal history?
Apotheek Jorissen Nv (FEI: 3000939205) has 6 FDA import refusal record(s) in our database, spanning from 8/12/2005 to 1/6/2006.
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. Apotheek Jorissen Nv's FEI number is 3000939205.
What types of violations has Apotheek Jorissen Nv received?
Apotheek Jorissen Nv 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 Apotheek Jorissen Nv come from?
All FDA import refusal data for Apotheek Jorissen 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.