Heel Belgium nv
⚠️ Moderate Risk
FEI: 3005193451 • Drongen, Oost-Vlaanderen • BELGIUM
FEI Number
3005193451
Location
Drongen, Oost-Vlaanderen
Country
BELGIUMAddress
Booiebos 25, , Drongen, 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
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).
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
Frequently Asked Questions
What is Heel Belgium nv's FDA import refusal history?
Heel Belgium nv (FEI: 3005193451) has 2 FDA import refusal record(s) in our database, spanning from 10/9/2003 to 11/29/2005.
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. Heel Belgium nv's FEI number is 3005193451.
What types of violations has Heel Belgium nv received?
Heel Belgium nv has been cited for 2 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 Heel Belgium nv come from?
All FDA import refusal data for Heel Belgium 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.