Bcb International
⚠️ Moderate Risk
FEI: 1000198022 • Cardiff • UNITED KINGDOM
FEI Number
1000198022
Location
Cardiff
Country
UNITED KINGDOMAddress
Clydesmuir Rd Ind Est, , Cardiff, , United Kingdom
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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/2/2015 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 3280FRNMFGREG | Philadelphia District Office (PHI-DO) |
| 12/2/2015 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 3280FRNMFGREG | Philadelphia District Office (PHI-DO) |
| 12/2/2015 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 3280FRNMFGREG | Philadelphia District Office (PHI-DO) |
| 9/12/2014 | 79FRODRESSING, WOUND, DRUG | Florida District Office (FLA-DO) | |
| 9/12/2014 | 80FQMBANDAGE, ELASTIC | Florida District Office (FLA-DO) | |
| 9/12/2014 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | Florida District Office (FLA-DO) | |
| 9/12/2014 | 79OHOFIRST AID KIT WITHOUT DRUG | Florida District Office (FLA-DO) | |
| 9/12/2014 | 80FQMBANDAGE, ELASTIC | Florida District Office (FLA-DO) | |
| 9/12/2014 | 79FRODRESSING, WOUND, DRUG | Florida District Office (FLA-DO) | |
| 9/12/2014 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | Florida District Office (FLA-DO) | |
| 9/12/2014 | 80KGXTAPE AND BANDAGE, ADHESIVE | Florida District Office (FLA-DO) | |
| 9/12/2014 | 80KGXTAPE AND BANDAGE, ADHESIVE | Florida District Office (FLA-DO) | |
| 9/12/2014 | 85HISCONDOM | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Bcb International's FDA import refusal history?
Bcb International (FEI: 1000198022) has 13 FDA import refusal record(s) in our database, spanning from 9/12/2014 to 12/2/2015.
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. Bcb International's FEI number is 1000198022.
What types of violations has Bcb International received?
Bcb International has been cited for 3 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 Bcb International come from?
All FDA import refusal data for Bcb International 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.