B&C International Nv
⚠️ Moderate Risk
FEI: 3004358329 • Mechelen, Antwerp • BELGIUM
FEI Number
3004358329
Location
Mechelen, Antwerp
Country
BELGIUMAddress
Wayenborgstraat 14, , Mechelen, Antwerp, 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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/20/2008 | 74OFMPHLEBOTOMY BLOOD COLLECTION KIT | New Orleans District Office (NOL-DO) | |
| 2/15/2006 | 79LROKIT, SURGICAL - GENERAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 2/15/2006 | 79LRRKIT, FIRST AID | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/3/2005 | 79FPXSTRIP, ADHESIVE, CLOSURE, SKIN | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/3/2005 | 79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/3/2005 | 78FHQHOLDER, NEEDLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/3/2005 | 80FORAPPLICATOR, ABSORBENT TIPPED | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/19/2005 | 80FORAPPLICATOR, ABSORBENT TIPPED | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/19/2005 | 79MGOCLOSURE, WOUND, ADHESIVE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/19/2005 | 81GIOTUBE, COLLECTION, CAPILLARY BLOOD | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/19/2005 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/19/2005 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/18/2005 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 5/18/2005 | 80KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/18/2005 | 79FPXSTRIP, ADHESIVE, CLOSURE, SKIN | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/18/2005 | 78FHQHOLDER, NEEDLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is B&C International Nv's FDA import refusal history?
B&C International Nv (FEI: 3004358329) has 16 FDA import refusal record(s) in our database, spanning from 5/18/2005 to 12/20/2008.
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. B&C International Nv's FEI number is 3004358329.
What types of violations has B&C International Nv received?
B&C International 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 B&C International Nv come from?
All FDA import refusal data for B&C International 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.