Ontex BVBA
⚠️ Moderate Risk
FEI: 3010692191 • Buggenhout, Oost-Vlaanderen • BELGIUM
FEI Number
3010692191
Location
Buggenhout, Oost-Vlaanderen
Country
BELGIUMAddress
Genthof 5, , Buggenhout, Oost-Vlaanderen, 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/28/2008 | 78EYQGARMENT, PROTECTIVE, FOR INCONTINENCE | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/28/2008 | 78EYQGARMENT, PROTECTIVE, FOR INCONTINENCE | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/28/2008 | 78EYQGARMENT, PROTECTIVE, FOR INCONTINENCE | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/28/2008 | 78EYQGARMENT, PROTECTIVE, FOR INCONTINENCE | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/28/2008 | 78EYQGARMENT, PROTECTIVE, FOR INCONTINENCE | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Ontex BVBA's FDA import refusal history?
Ontex BVBA (FEI: 3010692191) has 5 FDA import refusal record(s) in our database, spanning from 8/28/2008 to 8/28/2008.
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. Ontex BVBA's FEI number is 3010692191.
What types of violations has Ontex BVBA received?
Ontex BVBA has been cited for 1 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 Ontex BVBA come from?
All FDA import refusal data for Ontex BVBA 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.