Bluegnome Limited
⚠️ Moderate Risk
FEI: 3006514076 • Cambridge • UNITED KINGDOM
FEI Number
3006514076
Location
Cambridge
Country
UNITED KINGDOMAddress
Unit 5, Break House Mill, Cambridge, , 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
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 |
|---|---|---|---|
| 6/7/2012 | 81MAODNA-PROBE, HUMAN CHROMOSOME | New Orleans District Office (NOL-DO) | |
| 6/7/2012 | 81MAODNA-PROBE, HUMAN CHROMOSOME | New Orleans District Office (NOL-DO) | |
| 6/7/2012 | 81MAODNA-PROBE, HUMAN CHROMOSOME | New Orleans District Office (NOL-DO) | |
| 6/7/2012 | 81MAODNA-PROBE, HUMAN CHROMOSOME | New Orleans District Office (NOL-DO) | |
| 6/7/2012 | 81MAODNA-PROBE, HUMAN CHROMOSOME | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/7/2012 | 81MAODNA-PROBE, HUMAN CHROMOSOME | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/7/2012 | 81MAODNA-PROBE, HUMAN CHROMOSOME | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/7/2012 | 81MAODNA-PROBE, HUMAN CHROMOSOME | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/7/2012 | 81MAODNA-PROBE, HUMAN CHROMOSOME | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/7/2012 | 81MAODNA-PROBE, HUMAN CHROMOSOME | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/7/2011 | 81MAODNA-PROBE, HUMAN CHROMOSOME | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/2/2011 | 81MAODNA-PROBE, HUMAN CHROMOSOME | New Orleans District Office (NOL-DO) | |
| 3/2/2011 | 81MAODNA-PROBE, HUMAN CHROMOSOME | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/2/2011 | 81MAODNA-PROBE, HUMAN CHROMOSOME | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/1/2011 | 81MAODNA-PROBE, HUMAN CHROMOSOME | New Orleans District Office (NOL-DO) | |
| 3/1/2011 | 81MAODNA-PROBE, HUMAN CHROMOSOME | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bluegnome Limited's FDA import refusal history?
Bluegnome Limited (FEI: 3006514076) has 16 FDA import refusal record(s) in our database, spanning from 3/1/2011 to 6/7/2012.
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. Bluegnome Limited's FEI number is 3006514076.
What types of violations has Bluegnome Limited received?
Bluegnome Limited 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 Bluegnome Limited come from?
All FDA import refusal data for Bluegnome Limited 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.