Biorad Laboratories Europe Ltd
⚠️ Moderate Risk
FEI: 3003675282 • Perth • UNITED KINGDOM
FEI Number
3003675282
Location
Perth
Country
UNITED KINGDOMAddress
3 Riverview Business Park, , Perth, , 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/17/2011 | 81NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | Florida District Office (FLA-DO) | |
| 7/28/2010 | 81NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | 341REGISTERED | Florida District Office (FLA-DO) |
| 2/1/2010 | 81NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | Florida District Office (FLA-DO) | |
| 8/21/2009 | 80LDQDEVICE, GENERAL MEDICAL | Florida District Office (FLA-DO) | |
| 12/11/2008 | 81NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | Florida District Office (FLA-DO) | |
| 5/30/2007 | 81NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | Florida District Office (FLA-DO) | |
| 5/14/2007 | 81NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | Florida District Office (FLA-DO) | |
| 1/25/2007 | 81NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | Florida District Office (FLA-DO) | |
| 10/3/2006 | 81NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | Florida District Office (FLA-DO) | |
| 6/28/2006 | 81NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | Florida District Office (FLA-DO) | |
| 12/22/2005 | 81NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | Florida District Office (FLA-DO) | |
| 3/30/2005 | 80LDQDEVICE, GENERAL MEDICAL | Florida District Office (FLA-DO) | |
| 3/30/2005 | 80LDQDEVICE, GENERAL MEDICAL | Florida District Office (FLA-DO) | |
| 3/28/2005 | 81NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Biorad Laboratories Europe Ltd's FDA import refusal history?
Biorad Laboratories Europe Ltd (FEI: 3003675282) has 14 FDA import refusal record(s) in our database, spanning from 3/28/2005 to 5/17/2011.
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. Biorad Laboratories Europe Ltd's FEI number is 3003675282.
What types of violations has Biorad Laboratories Europe Ltd received?
Biorad Laboratories Europe Ltd 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 Biorad Laboratories Europe Ltd come from?
All FDA import refusal data for Biorad Laboratories Europe Ltd 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.