BARC NV Bioanalytical Research Corporation SA
⚠️ Moderate Risk
FEI: 3007907393 • Gent, Oost-vlaanderen • BELGIUM
FEI Number
3007907393
Location
Gent, Oost-vlaanderen
Country
BELGIUMAddress
Binnenring Zwijnaarde 3b, , Gent, 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).
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).
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/30/2014 | 89IMDPACK, HOT OR COLD, DISPOSABLE | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 7/22/2010 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 62NEEDS FCE | New Orleans District Office (NOL-DO) |
| 2/15/2006 | 75GIMTUBES, VACUUM SAMPLE, WITH ANTICOAGULANT | New Orleans District Office (NOL-DO) | |
| 2/15/2006 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is BARC NV Bioanalytical Research Corporation SA's FDA import refusal history?
BARC NV Bioanalytical Research Corporation SA (FEI: 3007907393) has 4 FDA import refusal record(s) in our database, spanning from 2/15/2006 to 9/30/2014.
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. BARC NV Bioanalytical Research Corporation SA's FEI number is 3007907393.
What types of violations has BARC NV Bioanalytical Research Corporation SA received?
BARC NV Bioanalytical Research Corporation SA 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 BARC NV Bioanalytical Research Corporation SA come from?
All FDA import refusal data for BARC NV Bioanalytical Research Corporation SA 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.